NDC 12578-409OTC monographFDA BULK INGREDIENT

Generic formulation

Active substance: Loperamide hydrochloride

50 formulations • 130 package configurations

All 180 registered NDCs — click to copy

In one line

Generic formulation (Loperamide hydrochloride) NDC 12578-409 converts to 12578-0409-00 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.

openFDA Live Registry SyncHIPAA 5-4-2 StandardCMS Level II Crosswalk

Listing: 12578-409

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

12578-0409-00

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

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
2 mg/1	66267-132-12	66267-132	66267-0132-12	12 CAPSULE in 1 BOTTLE (66267-132-12)
2 mg/1	66267-132-15	66267-132	66267-0132-15	15 CAPSULE in 1 BOTTLE (66267-132-15)
2 mg/1	66267-132-18	66267-132	66267-0132-18	18 CAPSULE in 1 BOTTLE (66267-132-18)
2 mg/1	66267-132-20	66267-132	66267-0132-20	20 CAPSULE in 1 BOTTLE (66267-132-20)
2 mg/1	66267-132-60	66267-132	66267-0132-60	15 CAPSULE in 1 BOTTLE (66267-132-60)
2 mg/1	67046-1676-3	67046-1676	67046-1676-03	30 CAPSULE in 1 BLISTER PACK (67046-1676-3)
2 mg/1	59556-959-05	59556-959	59556-0959-05	2 BLISTER PACK in 1 CARTON (59556-959-05) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (59556-959-03)
Inner component	59556-959-03	59556-959	59556-0959-03	Inner component of kit (59556-959-05)
2 mg/1	59556-959-06	59556-959	59556-0959-06	1 BLISTER PACK in 1 CARTON (59556-959-06) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (59556-959-03)
1 mg/7.5mL	46122-544-26	46122-544	46122-0544-26	120 mL in 1 BOTTLE (46122-544-26)
2 mg/1	48433-063-20	48433-063	48433-0063-20	100 BLISTER PACK in 1 CARTON (48433-063-20) / 1 CAPSULE in 1 BLISTER PACK (48433-063-01)
Inner component	48433-063-01	48433-063	48433-0063-01	Inner component of kit (48433-063-20)
2 mg/1	51079-690-20	51079-690	51079-0690-20	100 BLISTER PACK in 1 CARTON (51079-690-20) / 1 CAPSULE in 1 BLISTER PACK (51079-690-01)
Inner component	51079-690-01	51079-690	51079-0690-01	Inner component of kit (51079-690-20)
2 mg/1	71335-2111-0	71335-2111	71335-2111-00	50 CAPSULE in 1 BOTTLE (71335-2111-0)
2 mg/1	71335-2111-1	71335-2111	71335-2111-01	15 CAPSULE in 1 BOTTLE (71335-2111-1)
2 mg/1	71335-2111-2	71335-2111	71335-2111-02	30 CAPSULE in 1 BOTTLE (71335-2111-2)
2 mg/1	71335-2111-3	71335-2111	71335-2111-03	20 CAPSULE in 1 BOTTLE (71335-2111-3)
2 mg/1	71335-2111-4	71335-2111	71335-2111-04	12 CAPSULE in 1 BOTTLE (71335-2111-4)
2 mg/1	71335-2111-5	71335-2111	71335-2111-05	60 CAPSULE in 1 BOTTLE (71335-2111-5)
2 mg/1	71335-2111-6	71335-2111	71335-2111-06	24 CAPSULE in 1 BOTTLE (71335-2111-6)
2 mg/1	71335-2111-7	71335-2111	71335-2111-07	14 CAPSULE in 1 BOTTLE (71335-2111-7)
2 mg/1	71335-2111-8	71335-2111	71335-2111-08	9 CAPSULE in 1 BOTTLE (71335-2111-8)
2 mg/1	71335-2111-9	71335-2111	71335-2111-09	5 CAPSULE in 1 BOTTLE (71335-2111-9)
2 mg/1	72578-138-01	72578-138	72578-0138-01	100 CAPSULE in 1 BOTTLE (72578-138-01)
2 mg/1	72578-138-05	72578-138	72578-0138-05	500 CAPSULE in 1 BOTTLE (72578-138-05)
2 mg/1	72578-138-77	72578-138	72578-0138-77	10 BLISTER PACK in 1 CARTON (72578-138-77) / 10 CAPSULE in 1 BLISTER PACK (72578-138-30)
Inner component	72578-138-30	72578-138	72578-0138-30	Inner component of kit (72578-138-77)
1 mg/7.5mL	72288-645-34	72288-645	72288-0645-34	240 mL in 1 BOTTLE (72288-645-34)
2 mg/1, 125 mg/1	0363-9606-75	0363-9606	00363-9606-75	2 BLISTER PACK in 1 CARTON (0363-9606-75) / 6 TABLET in 1 BLISTER PACK
2 mg/1, 125 mg/1	0363-9606-76	0363-9606	00363-9606-76	4 BLISTER PACK in 1 CARTON (0363-9606-76) / 6 TABLET in 1 BLISTER PACK
2 mg/1	72603-328-01	72603-328	72603-0328-01	100 CAPSULE in 1 BOTTLE (72603-328-01)
2 mg/1	72603-328-02	72603-328	72603-0328-02	500 CAPSULE in 1 BOTTLE (72603-328-02)
2 mg/1	68016-123-06	68016-123	68016-0123-06	6 TABLET in 1 BLISTER PACK (68016-123-06)
2 mg/1	68016-123-18	68016-123	68016-0123-18	18 TABLET in 1 BLISTER PACK (68016-123-18)
2 mg/1	68016-123-24	68016-123	68016-0123-24	24 TABLET in 1 BLISTER PACK (68016-123-24)
2 mg/1	68016-123-97	68016-123	68016-0123-97	96 TABLET in 1 BOTTLE (68016-123-97)
2 mg/1, 125 mg/1	72288-001-62	72288-001	72288-0001-62	24 BLISTER PACK in 1 CARTON (72288-001-62) / 1 TABLET in 1 BLISTER PACK
2 mg/1	68071-3618-1	68071-3618	68071-3618-01	12 CAPSULE in 1 BOTTLE (68071-3618-1)
2 mg/1	68071-3618-2	68071-3618	68071-3618-02	20 CAPSULE in 1 BOTTLE (68071-3618-2)
1 mg/7.5mL	69452-405-55	69452-405	69452-0405-55	120 mL in 1 BOTTLE (69452-405-55)
1 mg/7.5mL	69452-405-93	69452-405	69452-0405-93	240 mL in 1 BOTTLE (69452-405-93)
2 mg/1	82804-295-06	82804-295	82804-0295-06	1 BLISTER PACK in 1 CARTON (82804-295-06) / 6 TABLET in 1 BLISTER PACK
2 mg/1	50268-482-15	50268-482	50268-0482-15	50 BLISTER PACK in 1 BOX (50268-482-15) / 1 CAPSULE in 1 BLISTER PACK (50268-482-11)
Inner component	50268-482-11	50268-482	50268-0482-11	Inner component of kit (50268-482-15)
1 mg/7.5mL	72288-048-34	72288-048	72288-0048-34	240 mL in 1 BOTTLE (72288-048-34)
2 mg/1	0615-8497-39	0615-8497	00615-8497-39	30 CAPSULE in 1 BLISTER PACK (0615-8497-39)
2 mg/1, 125 mg/1	62207-739-69	62207-739	62207-0739-69	2 BLISTER PACK in 1 CARTON (62207-739-69) / 6 TABLET in 1 BLISTER PACK
2 mg/1	70518-4283-0	70518-4283	70518-4283-00	30 CAPSULE in 1 BLISTER PACK (70518-4283-0)
2 mg/1	70518-4283-1	70518-4283	70518-4283-01	30 CAPSULE in 1 BLISTER PACK (70518-4283-1)
2 mg/1	70518-4283-2	70518-4283	70518-4283-02	15 CAPSULE in 1 BLISTER PACK (70518-4283-2)
2 mg/1	70518-4283-3	70518-4283	70518-4283-03	10 CAPSULE in 1 BLISTER PACK (70518-4283-3)
2 mg/1	70518-4283-4	70518-4283	70518-4283-04	20 CAPSULE in 1 BOTTLE, PLASTIC (70518-4283-4)
2 mg/1	70518-4283-5	70518-4283	70518-4283-05	50 POUCH in 1 BOX (70518-4283-5) / 1 CAPSULE in 1 POUCH (70518-4283-6)
Inner component	70518-4283-6	70518-4283	70518-4283-06	Inner component of kit (70518-4283-5)
2 mg/1	43598-770-24	43598-770	43598-0770-24	2 BLISTER PACK in 1 CARTON (43598-770-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2 mg/1	35418-123-12	35418-123	35418-0123-12	2 BLISTER PACK in 1 CARTON (35418-123-12) / 6 TABLET in 1 BLISTER PACK
1 mg/7.5mL	49035-451-34	49035-451	49035-0451-34	240 mL in 1 BOTTLE (49035-451-34)
1 mg/7.5mL	72288-758-26	72288-758	72288-0758-26	120 mL in 1 BOTTLE (72288-758-26)
2 mg/1, 125 mg/1	21130-222-24	21130-222	21130-0222-24	4 BLISTER PACK in 1 CARTON (21130-222-24) / 6 TABLET in 1 BLISTER PACK
2 mg/1, 125 mg/1	21130-222-76	21130-222	21130-0222-76	3 BLISTER PACK in 1 CARTON (21130-222-76) / 6 TABLET in 1 BLISTER PACK
1 mg/7.5mL	81033-067-34	81033-067	81033-0067-34	30 CUP, UNIT-DOSE in 1 CARTON (81033-067-34) / 7.5 mL in 1 CUP, UNIT-DOSE (81033-067-07)
Inner component	81033-067-07	81033-067	81033-0067-07	Inner component of kit (81033-067-34)
1 mg/7.5mL	81033-067-35	81033-067	81033-0067-35	30 CUP, UNIT-DOSE in 1 CARTON (81033-067-35) / 15 mL in 1 CUP, UNIT-DOSE (81033-067-15)
Inner component	81033-067-15	81033-067	81033-0067-15	Inner component of kit (81033-067-35)
2 mg/1	51660-123-06	51660-123	51660-0123-06	1 BLISTER PACK in 1 CARTON (51660-123-06) / 6 TABLET in 1 BLISTER PACK
2 mg/1	51660-123-12	51660-123	51660-0123-12	2 BLISTER PACK in 1 CARTON (51660-123-12) / 6 TABLET in 1 BLISTER PACK
2 mg/1	51660-123-24	51660-123	51660-0123-24	4 BLISTER PACK in 1 CARTON (51660-123-24) / 6 TABLET in 1 BLISTER PACK
2 mg/1	51407-999-01	51407-999	51407-0999-01	100 CAPSULE in 1 BOTTLE (51407-999-01)
2 mg/1	51407-999-05	51407-999	51407-0999-05	500 CAPSULE in 1 BOTTLE (51407-999-05)
2 mg/1, 125 mg/1	53041-263-50	53041-263	53041-0263-50	1 BLISTER PACK in 1 CARTON (53041-263-50) / 6 TABLET in 1 BLISTER PACK
2 mg/1	50090-0460-0	50090-0460	50090-0460-00	15 CAPSULE in 1 BOTTLE (50090-0460-0)
2 mg/1	50090-0460-3	50090-0460	50090-0460-03	12 CAPSULE in 1 BOTTLE (50090-0460-3)
2 mg/1	50090-0460-4	50090-0460	50090-0460-04	30 CAPSULE in 1 BOTTLE (50090-0460-4)
2 mg/1	68071-2257-6	68071-2257	68071-2257-06	6 CAPSULE in 1 BOTTLE (68071-2257-6)
2 mg/1	46122-738-53	46122-738	46122-0738-53	2 BLISTER PACK in 1 CARTON (46122-738-53) / 6 TABLET in 1 BLISTER PACK
2 mg/1	46122-738-62	46122-738	46122-0738-62	4 BLISTER PACK in 1 CARTON (46122-738-62) / 6 TABLET in 1 BLISTER PACK
2 mg/1, 125 mg/1	69452-531-12	69452-531	69452-0531-12	4 BLISTER PACK in 1 CARTON (69452-531-12) / 6 TABLET in 1 BLISTER PACK
2 mg/1	67296-2172-1	67296-2172	67296-2172-01	15 CAPSULE in 1 BOTTLE (67296-2172-1)
2 mg/1	71335-1921-0	71335-1921	71335-1921-00	50 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-0)
2 mg/1	71335-1921-1	71335-1921	71335-1921-01	15 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-1)
2 mg/1	71335-1921-2	71335-1921	71335-1921-02	30 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-2)
2 mg/1	71335-1921-3	71335-1921	71335-1921-03	20 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-3)
2 mg/1	71335-1921-4	71335-1921	71335-1921-04	12 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-4)
2 mg/1	71335-1921-5	71335-1921	71335-1921-05	60 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-5)
2 mg/1	71335-1921-6	71335-1921	71335-1921-06	24 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-6)
2 mg/1	71335-1921-7	71335-1921	71335-1921-07	14 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-7)
2 mg/1	71335-1921-8	71335-1921	71335-1921-08	9 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-8)
2 mg/1	71335-1921-9	71335-1921	71335-1921-09	5 CAPSULE in 1 BOTTLE, PLASTIC (71335-1921-9)
2 mg/1	71610-648-53	71610-648	71610-0648-53	60 CAPSULE in 1 BOTTLE (71610-648-53)
2 mg/1	71610-648-60	71610-648	71610-0648-60	90 CAPSULE in 1 BOTTLE (71610-648-60)
2 mg/1	70771-1769-1	70771-1769	70771-1769-01	100 CAPSULE in 1 BOTTLE (70771-1769-1)
2 mg/1	70771-1769-4	70771-1769	70771-1769-04	10 BLISTER PACK in 1 CARTON (70771-1769-4) / 10 CAPSULE in 1 BLISTER PACK (70771-1769-2)
Inner component	70771-1769-2	70771-1769	70771-1769-02	Inner component of kit (70771-1769-4)
2 mg/1	70771-1769-5	70771-1769	70771-1769-05	500 CAPSULE in 1 BOTTLE (70771-1769-5)
2 mg/1	71335-2487-0	71335-2487	71335-2487-00	50 CAPSULE in 1 BOTTLE (71335-2487-0)
2 mg/1	71335-2487-1	71335-2487	71335-2487-01	15 CAPSULE in 1 BOTTLE (71335-2487-1)
2 mg/1	71335-2487-2	71335-2487	71335-2487-02	30 CAPSULE in 1 BOTTLE (71335-2487-2)
2 mg/1	71335-2487-3	71335-2487	71335-2487-03	20 CAPSULE in 1 BOTTLE (71335-2487-3)
2 mg/1	71335-2487-4	71335-2487	71335-2487-04	12 CAPSULE in 1 BOTTLE (71335-2487-4)
2 mg/1	71335-2487-5	71335-2487	71335-2487-05	60 CAPSULE in 1 BOTTLE (71335-2487-5)
2 mg/1	71335-2487-6	71335-2487	71335-2487-06	24 CAPSULE in 1 BOTTLE (71335-2487-6)
2 mg/1	71335-2487-7	71335-2487	71335-2487-07	14 CAPSULE in 1 BOTTLE (71335-2487-7)
2 mg/1	71335-2487-8	71335-2487	71335-2487-08	9 CAPSULE in 1 BOTTLE (71335-2487-8)
2 mg/1	71335-2487-9	71335-2487	71335-2487-09	5 CAPSULE in 1 BOTTLE (71335-2487-9)
2 mg/1	72288-224-62	72288-224	72288-0224-62	24 BLISTER PACK in 1 CARTON (72288-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK
2 mg/1	58602-701-01	58602-701	58602-0701-01	1 BLISTER PACK in 1 CARTON (58602-701-01) / 6 TABLET in 1 BLISTER PACK
2 mg/1	58602-701-02	58602-701	58602-0701-02	2 BLISTER PACK in 1 CARTON (58602-701-02) / 6 TABLET in 1 BLISTER PACK
2 mg/1	58602-701-76	58602-701	58602-0701-76	4 BLISTER PACK in 1 CARTON (58602-701-76) / 6 TABLET in 1 BLISTER PACK
2 mg/1	72288-225-76	72288-225	72288-0225-76	4 BLISTER PACK in 1 CARTON (72288-225-76) / 6 TABLET in 1 BLISTER PACK
2 mg/1	63941-123-12	63941-123	63941-0123-12	12 TABLET in 1 BLISTER PACK (63941-123-12)
2 mg/1	63941-123-24	63941-123	63941-0123-24	24 TABLET in 1 BLISTER PACK (63941-123-24)
2 mg/1	75907-097-12	75907-097	75907-0097-12	1 BLISTER PACK in 1 CARTON (75907-097-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2 mg/1	75907-097-24	75907-097	75907-0097-24	2 BLISTER PACK in 1 CARTON (75907-097-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
1 mg/7.5mL	0904-6836-20	0904-6836	00904-6836-20	120 mL in 1 BOTTLE (0904-6836-20)
2 mg/1, 125 mg/1	79903-223-12	79903-223	79903-0223-12	2 BLISTER PACK in 1 CARTON (79903-223-12) / 6 TABLET in 1 BLISTER PACK
2 mg/1, 125 mg/1	79903-223-24	79903-223	79903-0223-24	4 BLISTER PACK in 1 CARTON (79903-223-24) / 6 TABLET in 1 BLISTER PACK
2 mg/1	55315-123-06	55315-123	55315-0123-06	6 TABLET in 1 BLISTER PACK (55315-123-06)
2 mg/1	55315-123-24	55315-123	55315-0123-24	24 TABLET in 1 BLISTER PACK (55315-123-24)
2 mg/1	58602-727-74	58602-727	58602-0727-74	1 BLISTER PACK in 1 CARTON (58602-727-74) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2 mg/1	58602-727-75	58602-727	58602-0727-75	2 BLISTER PACK in 1 CARTON (58602-727-75) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2 mg/1	58602-727-76	58602-727	58602-0727-76	4 BLISTER PACK in 1 CARTON (58602-727-76) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2 mg/1	58602-727-80	58602-727	58602-0727-80	3 BLISTER PACK in 1 CARTON (58602-727-80) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2 mg/1	72888-130-00	72888-130	72888-0130-00	1000 CAPSULE in 1 BOTTLE (72888-130-00)
2 mg/1	72888-130-01	72888-130	72888-0130-01	100 CAPSULE in 1 BOTTLE (72888-130-01)
2 mg/1	72888-130-05	72888-130	72888-0130-05	500 CAPSULE in 1 BOTTLE (72888-130-05)
2 mg/1	72888-130-30	72888-130	72888-0130-30	30 CAPSULE in 1 BOTTLE (72888-130-30)
2 mg/1	50090-7398-0	50090-7398	50090-7398-00	15 CAPSULE in 1 BOTTLE (50090-7398-0)
2 mg/1	50090-7398-3	50090-7398	50090-7398-03	12 CAPSULE in 1 BOTTLE (50090-7398-3)
2 mg/1	50090-7398-4	50090-7398	50090-7398-04	30 CAPSULE in 1 BOTTLE (50090-7398-4)

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

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Johnson & Johnson Innovative Medicine