NDC 65862-567OTC monographFDA DRUG FOR FURTHER PROCESSING

Generic formulation

Active substance: Montelukast Sodium

50 formulations • 149 package configurations

All 199 registered NDCs — click to copy

In one line

Generic formulation (Montelukast Sodium) NDC 65862-567 converts to 65862-0567-35 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.

FDA Approval & Market Entry Timeline

Official openFDA & DailyMed regulatory registration sequence

Listing: 65862-567 Verified

1. Initial Approval

2023

First U.S. FDA clearance for Montelukast Sodium

2. FDA Application

DRUG FOR FURTHER PROCESSING

Regulatory pathway: DRUG FOR FURTHER PROCESSING

3. Market Entry Date

Aug 3, 2012

First commercial NDC distribution & launch date

4. Regulatory Status

Active Commercial Listing

Registration valid through Dec 31, 2026

Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

Reimbursement channel

NDC direct

Oral / Topical formulation billed directly via 11-Digit NDC (No HCPCS J-Code required).

Standard pharmacy claim — no J-Code required

11-digit HIPAA NDC

65862-0567-35

Zero-padded 5-4-2 format

Standard conversion

CPT administration code

Self-Administered (Oral)

Dispensed via retail/mail pharmacy. No clinical administration procedure (CPT) required.

UB-04 revenue code

Rev 0250

0250 (General Pharmacy)

Qualifier: UN

Always verify NDC package code, billable multiplier, and invoice qualifier with specific payer guidelines before claim filing.

Every registered strength and package for Generic formulation, with 10-digit and 11-digit NDC formats
Formulation / role	Package NDC	Product NDC	11-digit HIPAA	Packaging detail
5 mg/1	55111-594-05	55111-594	55111-0594-05	500 TABLET, CHEWABLE in 1 BOTTLE (55111-594-05)
5 mg/1	55111-594-30	55111-594	55111-0594-30	30 TABLET, CHEWABLE in 1 BOTTLE (55111-594-30)
5 mg/1	55111-594-78	55111-594	55111-0594-78	10 BLISTER PACK in 1 CARTON (55111-594-78) / 10 TABLET, CHEWABLE in 1 BLISTER PACK (55111-594-79)
Inner component	55111-594-79	55111-594	55111-0594-79	Inner component of kit (55111-594-78)
5 mg/1	55111-594-90	55111-594	55111-0594-90	90 TABLET, CHEWABLE in 1 BOTTLE (55111-594-90)
5 mg/1	63187-896-30	63187-896	63187-0896-30	30 TABLET, CHEWABLE in 1 BOTTLE (63187-896-30)
5 mg/1	63187-896-60	63187-896	63187-0896-60	60 TABLET, CHEWABLE in 1 BOTTLE (63187-896-60)
5 mg/1	63187-896-90	63187-896	63187-0896-90	90 TABLET, CHEWABLE in 1 BOTTLE (63187-896-90)
10 mg/1	71335-1995-1	71335-1995	71335-1995-01	30 TABLET, FILM COATED in 1 BOTTLE (71335-1995-1)
10 mg/1	71335-1995-2	71335-1995	71335-1995-02	4 TABLET, FILM COATED in 1 BOTTLE (71335-1995-2)
10 mg/1	71335-1995-3	71335-1995	71335-1995-03	7 TABLET, FILM COATED in 1 BOTTLE (71335-1995-3)
10 mg/1	71335-1995-4	71335-1995	71335-1995-04	60 TABLET, FILM COATED in 1 BOTTLE (71335-1995-4)
10 mg/1	71335-1995-5	71335-1995	71335-1995-05	10 TABLET, FILM COATED in 1 BOTTLE (71335-1995-5)
10 mg/1	71335-1995-6	71335-1995	71335-1995-06	90 TABLET, FILM COATED in 1 BOTTLE (71335-1995-6)
10 mg/1	71335-1995-7	71335-1995	71335-1995-07	120 TABLET, FILM COATED in 1 BOTTLE (71335-1995-7)
10 mg/1	71335-1995-8	71335-1995	71335-1995-08	15 TABLET, FILM COATED in 1 BOTTLE (71335-1995-8)
10 mg/1	29300-220-01	29300-220	29300-0220-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-01)
10 mg/1	29300-220-10	29300-220	29300-0220-10	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-10)
10 mg/1	29300-220-13	29300-220	29300-0220-13	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-13)
10 mg/1	29300-220-19	29300-220	29300-0220-19	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-220-19)
4 mg/1	43063-381-21	43063-381	43063-0381-21	21 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-21)
4 mg/1	43063-381-30	43063-381	43063-0381-30	30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-30)
4 mg/1	29300-221-10	29300-221	29300-0221-10	1000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-221-10)
4 mg/1	29300-221-13	29300-221	29300-0221-13	30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-221-13)
4 mg/1	29300-221-19	29300-221	29300-0221-19	90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-221-19)
5 mg/1	29300-222-10	29300-222	29300-0222-10	1000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-222-10)
5 mg/1	29300-222-13	29300-222	29300-0222-13	30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-222-13)
5 mg/1	29300-222-19	29300-222	29300-0222-19	90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-222-19)
10 mg/1	68071-4047-3	68071-4047	68071-4047-03	30 TABLET, FILM COATED in 1 BOTTLE (68071-4047-3)
4 mg/500mg	13668-531-94	13668-531	13668-0531-94	30 PACKET in 1 CARTON (13668-531-94) / 500 mg in 1 PACKET (13668-531-11)
Inner component	13668-531-11	13668-531	13668-0531-11	Inner component of kit (13668-531-94)
4 mg/1	65862-567-05	65862-567	65862-0567-05	500 TABLET, CHEWABLE in 1 BOTTLE (65862-567-05)
4 mg/1	65862-567-30	65862-567	65862-0567-30	30 TABLET, CHEWABLE in 1 BOTTLE (65862-567-30)
4 mg/1	65862-567-90	65862-567	65862-0567-90	90 TABLET, CHEWABLE in 1 BOTTLE (65862-567-90)
5 mg/1	65862-568-05	65862-568	65862-0568-05	500 TABLET, CHEWABLE in 1 BOTTLE (65862-568-05)
5 mg/1	65862-568-30	65862-568	65862-0568-30	30 TABLET, CHEWABLE in 1 BOTTLE (65862-568-30)
5 mg/1	65862-568-90	65862-568	65862-0568-90	90 TABLET, CHEWABLE in 1 BOTTLE (65862-568-90)
10 mg/1	65862-574-10	65862-574	65862-0574-10	10 BLISTER PACK in 1 CARTON (65862-574-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
10 mg/1	65862-574-19	65862-574	65862-0574-19	10000 TABLET, FILM COATED in 1 BOTTLE (65862-574-19)
10 mg/1	65862-574-30	65862-574	65862-0574-30	30 TABLET, FILM COATED in 1 BOTTLE (65862-574-30)
10 mg/1	65862-574-90	65862-574	65862-0574-90	90 TABLET, FILM COATED in 1 BOTTLE (65862-574-90)
4 mg/1	55111-593-05	55111-593	55111-0593-05	500 TABLET, CHEWABLE in 1 BOTTLE (55111-593-05)
4 mg/1	55111-593-30	55111-593	55111-0593-30	30 TABLET, CHEWABLE in 1 BOTTLE (55111-593-30)
4 mg/1	55111-593-78	55111-593	55111-0593-78	10 BLISTER PACK in 1 CARTON (55111-593-78) / 10 TABLET, CHEWABLE in 1 BLISTER PACK (55111-593-79)
Inner component	55111-593-79	55111-593	55111-0593-79	Inner component of kit (55111-593-78)
4 mg/1	55111-593-90	55111-593	55111-0593-90	90 TABLET, CHEWABLE in 1 BOTTLE (55111-593-90)
10 mg/1	69367-287-05	69367-287	69367-0287-05	500 TABLET in 1 BOTTLE (69367-287-05)
10 mg/1	69367-287-09	69367-287	69367-0287-09	90 TABLET in 1 BOTTLE (69367-287-09)
4 mg/1	57237-212-30	57237-212	57237-0212-30	30 TABLET, CHEWABLE in 1 BOTTLE (57237-212-30)
4 mg/1	57237-212-90	57237-212	57237-0212-90	90 TABLET, CHEWABLE in 1 BOTTLE (57237-212-90)
5 mg/1	57237-213-30	57237-213	57237-0213-30	30 TABLET, CHEWABLE in 1 BOTTLE (57237-213-30)
5 mg/1	57237-213-90	57237-213	57237-0213-90	90 TABLET, CHEWABLE in 1 BOTTLE (57237-213-90)
4 mg/1	42291-622-10	42291-622	42291-0622-10	1000 TABLET, CHEWABLE in 1 BOTTLE (42291-622-10)
4 mg/1	42291-622-30	42291-622	42291-0622-30	30 TABLET, CHEWABLE in 1 BOTTLE (42291-622-30)
4 mg/1	42291-622-90	42291-622	42291-0622-90	90 TABLET, CHEWABLE in 1 BOTTLE (42291-622-90)
5 mg/1	42291-623-10	42291-623	42291-0623-10	1000 TABLET, CHEWABLE in 1 BOTTLE (42291-623-10)
5 mg/1	42291-623-30	42291-623	42291-0623-30	30 TABLET, CHEWABLE in 1 BOTTLE (42291-623-30)
5 mg/1	42291-623-90	42291-623	42291-0623-90	90 TABLET, CHEWABLE in 1 BOTTLE (42291-623-90)
10 mg/1	67296-1926-3	67296-1926	67296-1926-03	30 TABLET, FILM COATED in 1 BOTTLE (67296-1926-3)
10 mg/1	0904-6808-06	0904-6808	00904-6808-06	50 BLISTER PACK in 1 CARTON (0904-6808-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
10 mg/1	0904-6808-61	0904-6808	00904-6808-61	100 BLISTER PACK in 1 CARTON (0904-6808-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
10 mg/1	57237-255-30	57237-255	57237-0255-30	30 TABLET, FILM COATED in 1 BOTTLE (57237-255-30)
10 mg/1	57237-255-90	57237-255	57237-0255-90	90 TABLET, FILM COATED in 1 BOTTLE (57237-255-90)
10 mg/1	55111-725-01	55111-725	55111-0725-01	100 TABLET, COATED in 1 BOTTLE (55111-725-01)
10 mg/1	55111-725-10	55111-725	55111-0725-10	1000 TABLET, COATED in 1 BOTTLE (55111-725-10)
10 mg/1	55111-725-30	55111-725	55111-0725-30	30 TABLET, COATED in 1 BOTTLE (55111-725-30)
10 mg/1	55111-725-78	55111-725	55111-0725-78	10 BLISTER PACK in 1 CARTON (55111-725-78) / 10 TABLET, COATED in 1 BLISTER PACK (55111-725-79)
Inner component	55111-725-79	55111-725	55111-0725-79	Inner component of kit (55111-725-78)
10 mg/1	55111-725-90	55111-725	55111-0725-90	90 TABLET, COATED in 1 BOTTLE (55111-725-90)
10 mg/1	16729-119-10	16729-119	16729-0119-10	30 TABLET, FILM COATED in 1 BOTTLE (16729-119-10)
10 mg/1	16729-119-15	16729-119	16729-0119-15	90 TABLET, FILM COATED in 1 BOTTLE (16729-119-15)
10 mg/1	16729-119-17	16729-119	16729-0119-17	1000 TABLET, FILM COATED in 1 BOTTLE (16729-119-17)
4 mg/1	59651-329-30	59651-329	59651-0329-30	30 PACKET in 1 CARTON (59651-329-30) / 1 GRANULE in 1 PACKET (59651-329-05)
Inner component	59651-329-05	59651-329	59651-0329-05	Inner component of kit (59651-329-30)
10 mg/1	55154-8075-0	55154-8075	55154-8075-00	10 BLISTER PACK in 1 BAG (55154-8075-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
4 mg/1	62135-781-30	62135-781	62135-0781-30	30 TABLET, CHEWABLE in 1 BOTTLE (62135-781-30)
5 mg/1	62135-782-30	62135-782	62135-0782-30	30 TABLET, CHEWABLE in 1 BOTTLE (62135-782-30)
4 mg/1	50090-2921-0	50090-2921	50090-2921-00	30 TABLET, CHEWABLE in 1 BOTTLE (50090-2921-0)
4 mg/1	50090-2921-1	50090-2921	50090-2921-01	90 TABLET, CHEWABLE in 1 BOTTLE (50090-2921-1)
4 mg/1	27241-015-31	27241-015	27241-0015-31	30 GRANULE in 1 CARTON (27241-015-31)
4 mg/1	27241-016-03	27241-016	27241-0016-03	30 TABLET, CHEWABLE in 1 BOTTLE (27241-016-03)
4 mg/1	27241-016-09	27241-016	27241-0016-09	90 TABLET, CHEWABLE in 1 BOTTLE (27241-016-09)
5 mg/1	27241-017-03	27241-017	27241-0017-03	30 TABLET, CHEWABLE in 1 BOTTLE (27241-017-03)
5 mg/1	27241-017-09	27241-017	27241-0017-09	90 TABLET, CHEWABLE in 1 BOTTLE (27241-017-09)
10 mg/1	27241-018-03	27241-018	27241-0018-03	30 TABLET, COATED in 1 BOTTLE (27241-018-03)
10 mg/1	27241-018-09	27241-018	27241-0018-09	90 TABLET, COATED in 1 BOTTLE (27241-018-09)
10 mg/1	27241-018-90	27241-018	27241-0018-90	1000 TABLET, COATED in 1 BOTTLE (27241-018-90)
10 mg/1	72189-418-30	72189-418	72189-0418-30	30 TABLET, FILM COATED in 1 BOTTLE (72189-418-30)
10 mg/1	72189-418-90	72189-418	72189-0418-90	90 TABLET, FILM COATED in 1 BOTTLE (72189-418-90)
10 mg/1	63187-692-30	63187-692	63187-0692-30	30 TABLET, COATED in 1 BOTTLE (63187-692-30)
10 mg/1	63187-692-60	63187-692	63187-0692-60	60 TABLET, COATED in 1 BOTTLE (63187-692-60)
10 mg/1	63187-692-90	63187-692	63187-0692-90	90 TABLET, COATED in 1 BOTTLE (63187-692-90)
10 mg/1	70518-4753-0	70518-4753	70518-4753-00	90 TABLET in 1 BOTTLE, PLASTIC (70518-4753-0)
10 mg/1	43063-762-30	43063-762	43063-0762-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-762-30)
10 mg/1	72789-306-30	72789-306	72789-0306-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-306-30)
10 mg/1	31722-726-01	31722-726	31722-0726-01	100 TABLET, FILM COATED in 1 BOTTLE (31722-726-01)
10 mg/1	31722-726-10	31722-726	31722-0726-10	1000 TABLET, FILM COATED in 1 BOTTLE (31722-726-10)
10 mg/1	31722-726-30	31722-726	31722-0726-30	30 TABLET, FILM COATED in 1 BOTTLE (31722-726-30)
10 mg/1	31722-726-32	31722-726	31722-0726-32	10 BLISTER PACK in 1 CARTON (31722-726-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-726-31)
Inner component	31722-726-31	31722-726	31722-0726-31	Inner component of kit (31722-726-32)
10 mg/1	31722-726-90	31722-726	31722-0726-90	90 TABLET, FILM COATED in 1 BOTTLE (31722-726-90)
4 mg/1	31722-727-01	31722-727	31722-0727-01	100 TABLET, CHEWABLE in 1 BOTTLE (31722-727-01)
4 mg/1	31722-727-10	31722-727	31722-0727-10	1000 TABLET, CHEWABLE in 1 BOTTLE (31722-727-10)
4 mg/1	31722-727-30	31722-727	31722-0727-30	30 TABLET, CHEWABLE in 1 BOTTLE (31722-727-30)
4 mg/1	31722-727-31	31722-727	31722-0727-31	10 TABLET, CHEWABLE in 1 BLISTER PACK (31722-727-31)
4 mg/1	31722-727-32	31722-727	31722-0727-32	100 TABLET, CHEWABLE in 1 CARTON (31722-727-32)
4 mg/1	31722-727-90	31722-727	31722-0727-90	90 TABLET, CHEWABLE in 1 BOTTLE (31722-727-90)
5 mg/1	31722-728-01	31722-728	31722-0728-01	100 TABLET, CHEWABLE in 1 BOTTLE (31722-728-01)
5 mg/1	31722-728-10	31722-728	31722-0728-10	1000 TABLET, CHEWABLE in 1 BOTTLE (31722-728-10)
5 mg/1	31722-728-30	31722-728	31722-0728-30	30 TABLET, CHEWABLE in 1 BOTTLE (31722-728-30)
5 mg/1	31722-728-31	31722-728	31722-0728-31	10 TABLET, CHEWABLE in 1 BLISTER PACK (31722-728-31)
5 mg/1	31722-728-32	31722-728	31722-0728-32	100 TABLET, CHEWABLE in 1 CARTON (31722-728-32)
5 mg/1	31722-728-90	31722-728	31722-0728-90	90 TABLET, CHEWABLE in 1 BOTTLE (31722-728-90)
4 mg/1	63187-550-30	63187-550	63187-0550-30	30 TABLET, CHEWABLE in 1 BOTTLE (63187-550-30)
4 mg/1	63187-550-60	63187-550	63187-0550-60	60 TABLET, CHEWABLE in 1 BOTTLE (63187-550-60)
4 mg/1	63187-550-90	63187-550	63187-0550-90	90 TABLET, CHEWABLE in 1 BOTTLE (63187-550-90)
4 mg/1	62175-204-32	62175-204	62175-0204-32	30 TABLET, CHEWABLE in 1 BOTTLE (62175-204-32)
4 mg/1	62175-204-43	62175-204	62175-0204-43	1000 TABLET, CHEWABLE in 1 BOTTLE (62175-204-43)
4 mg/1	62175-204-46	62175-204	62175-0204-46	90 TABLET, CHEWABLE in 1 BOTTLE (62175-204-46)
5 mg/1	62175-205-32	62175-205	62175-0205-32	30 TABLET, CHEWABLE in 1 BOTTLE (62175-205-32)
5 mg/1	62175-205-43	62175-205	62175-0205-43	1000 TABLET, CHEWABLE in 1 BOTTLE (62175-205-43)
5 mg/1	62175-205-46	62175-205	62175-0205-46	90 TABLET, CHEWABLE in 1 BOTTLE (62175-205-46)
10 mg/1	65162-732-03	65162-732	65162-0732-03	30 TABLET in 1 BOTTLE (65162-732-03)
10 mg/1	65162-732-09	65162-732	65162-0732-09	90 TABLET in 1 BOTTLE (65162-732-09)
10 mg/1	65162-732-11	65162-732	65162-0732-11	1000 TABLET in 1 BOTTLE (65162-732-11)
4 mg/1	13668-079-05	13668-079	13668-0079-05	500 TABLET, CHEWABLE in 1 BOTTLE (13668-079-05)
4 mg/1	13668-079-30	13668-079	13668-0079-30	30 TABLET, CHEWABLE in 1 BOTTLE (13668-079-30)
4 mg/1	13668-079-90	13668-079	13668-0079-90	90 TABLET, CHEWABLE in 1 BOTTLE (13668-079-90)
5 mg/1	13668-080-05	13668-080	13668-0080-05	500 TABLET, CHEWABLE in 1 BOTTLE (13668-080-05)
5 mg/1	13668-080-30	13668-080	13668-0080-30	30 TABLET, CHEWABLE in 1 BOTTLE (13668-080-30)
5 mg/1	13668-080-90	13668-080	13668-0080-90	90 TABLET, CHEWABLE in 1 BOTTLE (13668-080-90)
10 mg/1	71335-0514-1	71335-0514	71335-0514-01	30 TABLET, FILM COATED in 1 BOTTLE (71335-0514-1)
10 mg/1	71335-0514-2	71335-0514	71335-0514-02	4 TABLET, FILM COATED in 1 BOTTLE (71335-0514-2)
10 mg/1	71335-0514-3	71335-0514	71335-0514-03	7 TABLET, FILM COATED in 1 BOTTLE (71335-0514-3)
10 mg/1	71335-0514-4	71335-0514	71335-0514-04	60 TABLET, FILM COATED in 1 BOTTLE (71335-0514-4)
10 mg/1	71335-0514-5	71335-0514	71335-0514-05	10 TABLET, FILM COATED in 1 BOTTLE (71335-0514-5)
10 mg/1	71335-0514-6	71335-0514	71335-0514-06	90 TABLET, FILM COATED in 1 BOTTLE (71335-0514-6)
10 mg/1	71335-0514-7	71335-0514	71335-0514-07	120 TABLET, FILM COATED in 1 BOTTLE (71335-0514-7)
10 mg/1	71335-0514-8	71335-0514	71335-0514-08	15 TABLET, FILM COATED in 1 BOTTLE (71335-0514-8)
10 mg/1	13668-081-05	13668-081	13668-0081-05	500 TABLET in 1 BOTTLE (13668-081-05)
10 mg/1	13668-081-30	13668-081	13668-0081-30	30 TABLET in 1 BOTTLE (13668-081-30)
10 mg/1	13668-081-32	13668-081	13668-0081-32	3200 TABLET in 1 BOTTLE (13668-081-32)
10 mg/1	13668-081-74	13668-081	13668-0081-74	100 TABLET in 1 CARTON (13668-081-74)
10 mg/1	13668-081-90	13668-081	13668-0081-90	90 TABLET in 1 BOTTLE (13668-081-90)
5 mg/1	71205-128-30	71205-128	71205-0128-30	30 TABLET, CHEWABLE in 1 BOTTLE (71205-128-30)
5 mg/1	71205-128-60	71205-128	71205-0128-60	60 TABLET, CHEWABLE in 1 BOTTLE (71205-128-60)
5 mg/1	71205-128-90	71205-128	71205-0128-90	90 TABLET, CHEWABLE in 1 BOTTLE (71205-128-90)
4 mg/1	50268-573-15	50268-573	50268-0573-15	50 BLISTER PACK in 1 BOX (50268-573-15) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (50268-573-11)
Inner component	50268-573-11	50268-573	50268-0573-11	Inner component of kit (50268-573-15)

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary. Initial U.S. approval: 2023.

Highlights

These highlights do not include all the information needed to use Generic formulation safely and effectively. The full sections follow.

Indications and usage: AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: • Individuals 60 years of age and older. • Individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Limitations of Use: AREXVY is not for use in pregnant individuals.
Dosage and administration: For intramuscular use only. • After reconstitution, a single dose of AREXVY is either 0.5 mL (vial and vial presentation) or approximately 0.5 mL (vial and prefilled syringe presentation). • Supplied as two presentations: (1) Vial of Lyophilized Antigen Component reconstituted with accompanying Adjuvant Suspension Component vial; (2) Vial of Lyophilized Antigen Component reconstituted with accompanying prefilled syringe of Adjuvant Suspension Component.
Dosage forms and strengths: For injectable suspension: Single dose after reconstitution is 0.5 mL (vial/vial) or approximately 0.5 mL (vial/prefilled syringe).
Contraindications: History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
Warnings and precautions: • Guillain-Barré Syndrome: Postmarketing observational study suggests an increased risk of Guillain-Barré syndrome during the 42 days following vaccination. • Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions. • Syncope: Syncope (fainting) may occur; procedures should be in place to avoid injury from falling. • Altered Immunocompetence: Immunocompromised persons may have a diminished immune response.
Adverse reactions: • Most commonly reported adverse reactions (≥10%) in adults ≥60 years: injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%). • In adults 50–59 years: injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%). • In adults 18–49 years: injection site pain (76.0%), myalgia (59.9%), fatigue (59.6%), headache (43.6%), and arthralgia (28.3%).

13 Label Sections

INDICATIONS AND USAGE

AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: • Individuals 60 years of age and older. • Individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Limitations of Use: AREXVY is not for use in pregnant individuals [see Use in Specific Populations (8.1)].

DOSAGE AND ADMINISTRATION

2.1 Dose and Schedule After reconstitution, a single dose of AREXVY is either 0.5 mL (vial and vial presentation) or approximately 0.5 mL (vial and prefilled syringe presentation). 2.2 Preparation & Reconstitution Instructions AREXVY is supplied in two presentations that must be combined prior to administration: • Vial and Vial Presentation: Reconstitute the Lyophilized Antigen Component (sterile white powder) with the accompanying Adjuvant Suspension Component (opalescent, colorless to pale brownish liquid). Use only the supplied Adjuvant Suspension Component for reconstitution. Withdraw entire contents of adjuvant vial and slowly transfer into antigen powder vial. Gently swirl until completely dissolved. • Vial and Prefilled Syringe Presentation: Reconstitute the Lyophilized Antigen Component vial with the accompanying prefilled syringe of Adjuvant Suspension Component. Slowly transfer entire contents into antigen vial and gently swirl until powder dissolves. 2.3 Administration For intramuscular (IM) injection only, preferably in the deltoid region. After reconstitution, administer AREXVY immediately or store protected from light in the refrigerator between 2°C and 8°C (36°F to 46°F) or at room temperature [up to 25°C (77°F)] and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours.

DOSAGE FORMS AND STRENGTHS

For injectable suspension. • For the vial and vial presentation, a single dose after reconstitution is 0.5 mL. • For the vial and prefilled syringe presentation, a single dose after reconstitution is approximately 0.5 mL.

CONTRAINDICATIONS

Do not administer AREXVY to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of AREXVY [see Description (11)].

WARNINGS AND PRECAUTIONS

5.1 Guillain-Barré Syndrome The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with AREXVY [see Adverse Reactions (6.2)]. 5.2 Preventing and Managing Allergic Reactions Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY. 5.3 Syncope Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting. 5.4 Altered Immunocompetence Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY.

ADVERSE REACTIONS

6.1 Clinical Trials Experience The safety of AREXVY was evaluated in over 17,879 vaccine recipients in multi-center clinical trials (Study 1: NCT04886596 in 24,966 participants). Most Commonly Reported Solicited Adverse Reactions: • Adults ≥60 years: Injection site pain (60.9%), Fatigue (33.6%), Myalgia (28.9%), Headache (27.2%), Arthralgia (18.1%), Erythema (7.5%), Swelling (5.5%), Fever (2.0%). • Adults 50–59 years: Injection site pain (75.8%), Fatigue (39.8%), Myalgia (35.6%), Headache (31.7%), Arthralgia (23.4%), Erythema (13.2%), Swelling (10.4%). • Adults 18–49 years: Injection site pain (76.0%), Myalgia (59.9%), Fatigue (59.6%), Headache (43.6%), Arthralgia (28.3%). 6.2 Postmarketing Experience Postmarketing surveillance identified cases of Guillain-Barré syndrome and acute hypersensitivity reactions following administration.

DRUG INTERACTIONS & CONCOMITANT ADMINISTRATION

USE IN SPECIFIC POPULATIONS

DESCRIPTION

CLINICAL PHARMACOLOGY

CLINICAL STUDIES

HOW SUPPLIED / STORAGE AND HANDLING

AREXVY is supplied as: • Outer Carton Kit (58160-848-11): 1 vial of Lyophilized Antigen Component (58160-723-03) and 1 vial of Adjuvant Suspension Component (58160-744-03). • Outer Carton Kit (58160-894-15): 1 vial of Lyophilized Antigen Component (58160-719-03) and 1 prefilled syringe of Adjuvant Suspension Component (58160-749-07). • Outer Carton Kit (58160-882-12): 1 vial of Lyophilized Antigen Component (58160-719-03) and 1 prefilled syringe of Adjuvant Suspension Component (58160-749-07). Storage before Reconstitution: Store in refrigerator between 2°C and 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Discard if frozen. Storage after Reconstitution: Use immediately or store in refrigerator at 2°C to 8°C or room temperature up to 25°C (77°F) for up to 4 hours.

PATIENT COUNSELING INFORMATION

Terms used here11-digit NDC Package NDC N4 qualifier

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