NDC 65862-416OTC monographFDA BULK INGREDIENT

Generic formulation

Active substance: Metoprolol Tartrate

50 formulations • 132 package configurations

All 181 registered NDCs — click to copy

In one line

Generic formulation (Metoprolol Tartrate) NDC 65862-416 converts to 65862-0416-37 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: 65862-416 Verified

1. Initial Approval

2023

First U.S. FDA clearance for Metoprolol Tartrate

2. FDA Application

BULK INGREDIENT

Regulatory pathway: BULK INGREDIENT

3. Market Entry Date

Nov 4, 2023

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

65862-0416-37

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
50 mg/1	68071-4957-1	68071-4957	68071-4957-01	100 TABLET, FILM COATED in 1 BOTTLE (68071-4957-1)
100 mg/1	68071-4958-1	68071-4958	68071-4958-01	100 TABLET, FILM COATED in 1 BOTTLE (68071-4958-1)
1 mg/mL	55154-1557-5	55154-1557	55154-1557-05	5 VIAL, SINGLE-DOSE in 1 BAG (55154-1557-5) / 5 mL in 1 VIAL, SINGLE-DOSE
50 mg/1	82804-978-00	82804-978	82804-0978-00	100 TABLET in 1 BOTTLE (82804-978-00)
50 mg/1	82804-978-11	82804-978	82804-0978-11	1000 TABLET in 1 BOTTLE (82804-978-11)
50 mg/1	82804-978-30	82804-978	82804-0978-30	30 TABLET in 1 BOTTLE (82804-978-30)
50 mg/1	82804-978-55	82804-978	82804-0978-55	500 TABLET in 1 BOTTLE (82804-978-55)
50 mg/1	82804-978-60	82804-978	82804-0978-60	60 TABLET in 1 BOTTLE (82804-978-60)
50 mg/1	82804-978-90	82804-978	82804-0978-90	90 TABLET in 1 BOTTLE (82804-978-90)
100 mg/1	72189-544-30	72189-544	72189-0544-30	30 TABLET, FILM COATED in 1 BOTTLE (72189-544-30)
100 mg/1	72189-544-90	72189-544	72189-0544-90	90 TABLET, FILM COATED in 1 BOTTLE (72189-544-90)
100 mg/1	82804-979-00	82804-979	82804-0979-00	100 TABLET in 1 BOTTLE (82804-979-00)
100 mg/1	82804-979-11	82804-979	82804-0979-11	1000 TABLET in 1 BOTTLE (82804-979-11)
100 mg/1	82804-979-30	82804-979	82804-0979-30	30 TABLET in 1 BOTTLE (82804-979-30)
100 mg/1	82804-979-55	82804-979	82804-0979-55	500 TABLET in 1 BOTTLE (82804-979-55)
100 mg/1	82804-979-60	82804-979	82804-0979-60	60 TABLET in 1 BOTTLE (82804-979-60)
100 mg/1	82804-979-90	82804-979	82804-0979-90	90 TABLET in 1 BOTTLE (82804-979-90)
50 mg/1	55154-5512-0	55154-5512	55154-5512-00	10 BLISTER PACK in 1 BAG (55154-5512-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
100 mg/1	71335-9716-1	71335-9716	71335-9716-01	30 TABLET, FILM COATED in 1 BOTTLE (71335-9716-1)
100 mg/1	71335-9716-2	71335-9716	71335-9716-02	100 TABLET, FILM COATED in 1 BOTTLE (71335-9716-2)
100 mg/1	71335-9716-3	71335-9716	71335-9716-03	60 TABLET, FILM COATED in 1 BOTTLE (71335-9716-3)
100 mg/1	71335-9716-4	71335-9716	71335-9716-04	90 TABLET, FILM COATED in 1 BOTTLE (71335-9716-4)
100 mg/1	71335-9716-5	71335-9716	71335-9716-05	180 TABLET, FILM COATED in 1 BOTTLE (71335-9716-5)
50 mg/1	51655-281-25	51655-281	51655-0281-25	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-281-25)Sample
100 mg/1	55154-2126-0	55154-2126	55154-2126-00	10 BLISTER PACK in 1 BAG (55154-2126-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
25 mg/1	71335-0192-1	71335-0192	71335-0192-01	30 TABLET, FILM COATED in 1 BOTTLE (71335-0192-1)
25 mg/1	71335-0192-2	71335-0192	71335-0192-02	60 TABLET, FILM COATED in 1 BOTTLE (71335-0192-2)
25 mg/1	71335-0192-3	71335-0192	71335-0192-03	90 TABLET, FILM COATED in 1 BOTTLE (71335-0192-3)
25 mg/1	71335-0192-4	71335-0192	71335-0192-04	180 TABLET, FILM COATED in 1 BOTTLE (71335-0192-4)
25 mg/1	71335-0192-5	71335-0192	71335-0192-05	100 TABLET, FILM COATED in 1 BOTTLE (71335-0192-5)
25 mg/1	71335-0192-6	71335-0192	71335-0192-06	120 TABLET, FILM COATED in 1 BOTTLE (71335-0192-6)
25 mg/1	71335-0192-7	71335-0192	71335-0192-07	20 TABLET, FILM COATED in 1 BOTTLE (71335-0192-7)
25 mg/1	71335-0192-8	71335-0192	71335-0192-08	10 TABLET, FILM COATED in 1 BOTTLE (71335-0192-8)
25 mg/1	50090-7738-0	50090-7738	50090-7738-00	180 TABLET in 1 BOTTLE (50090-7738-0)
25 mg/1	50090-7738-1	50090-7738	50090-7738-01	60 TABLET in 1 BOTTLE (50090-7738-1)
25 mg/1	50090-7738-2	50090-7738	50090-7738-02	90 TABLET in 1 BOTTLE (50090-7738-2)
25 mg/1	50090-7738-3	50090-7738	50090-7738-03	30 TABLET in 1 BOTTLE (50090-7738-3)
25 mg/1	50090-7739-0	50090-7739	50090-7739-00	90 TABLET in 1 BOTTLE (50090-7739-0)
100 mg/1	50090-7740-0	50090-7740	50090-7740-00	30 TABLET, FILM COATED in 1 BOTTLE (50090-7740-0)
100 mg/1	50090-7740-1	50090-7740	50090-7740-01	60 TABLET, FILM COATED in 1 BOTTLE (50090-7740-1)
100 mg/1	50090-7740-3	50090-7740	50090-7740-03	90 TABLET, FILM COATED in 1 BOTTLE (50090-7740-3)
100 mg/1	50090-7740-4	50090-7740	50090-7740-04	180 TABLET, FILM COATED in 1 BOTTLE (50090-7740-4)
25 mg/1	65862-062-01	65862-062	65862-0062-01	100 TABLET, FILM COATED in 1 BOTTLE (65862-062-01)
25 mg/1	65862-062-99	65862-062	65862-0062-99	1000 TABLET, FILM COATED in 1 BOTTLE (65862-062-99)
100 mg/1	50090-7741-0	50090-7741	50090-7741-00	90 TABLET, FILM COATED in 1 BOTTLE (50090-7741-0)
25 mg/1	57237-100-01	57237-100	57237-0100-01	100 TABLET, FILM COATED in 1 BOTTLE (57237-100-01)
25 mg/1	57237-100-99	57237-100	57237-0100-99	1000 TABLET, FILM COATED in 1 BOTTLE (57237-100-99)
50 mg/1	65862-063-01	65862-063	65862-0063-01	100 TABLET, FILM COATED in 1 BOTTLE (65862-063-01)
50 mg/1	65862-063-60	65862-063	65862-0063-60	60 TABLET, FILM COATED in 1 BOTTLE (65862-063-60)
50 mg/1	65862-063-99	65862-063	65862-0063-99	1000 TABLET, FILM COATED in 1 BOTTLE (65862-063-99)
50 mg/1	57237-101-01	57237-101	57237-0101-01	100 TABLET, FILM COATED in 1 BOTTLE (57237-101-01)
50 mg/1	57237-101-99	57237-101	57237-0101-99	1000 TABLET, FILM COATED in 1 BOTTLE (57237-101-99)
100 mg/1	65862-064-01	65862-064	65862-0064-01	100 TABLET, FILM COATED in 1 BOTTLE (65862-064-01)
100 mg/1	65862-064-60	65862-064	65862-0064-60	60 TABLET, FILM COATED in 1 BOTTLE (65862-064-60)
100 mg/1	65862-064-99	65862-064	65862-0064-99	1000 TABLET, FILM COATED in 1 BOTTLE (65862-064-99)
100 mg/1	67046-1626-3	67046-1626	67046-1626-03	30 TABLET in 1 BLISTER PACK (67046-1626-3)
25 mg/1	50090-2207-0	50090-2207	50090-2207-00	180 TABLET, FILM COATED in 1 BOTTLE (50090-2207-0)
25 mg/1	50090-2207-1	50090-2207	50090-2207-01	60 TABLET, FILM COATED in 1 BOTTLE (50090-2207-1)
25 mg/1	50090-2207-2	50090-2207	50090-2207-02	90 TABLET, FILM COATED in 1 BOTTLE (50090-2207-2)
25 mg/1	50090-2207-3	50090-2207	50090-2207-03	30 TABLET, FILM COATED in 1 BOTTLE (50090-2207-3)
100 mg/1	57237-102-01	57237-102	57237-0102-01	100 TABLET, FILM COATED in 1 BOTTLE (57237-102-01)
100 mg/1	57237-102-99	57237-102	57237-0102-99	1000 TABLET, FILM COATED in 1 BOTTLE (57237-102-99)
100 mg/1	60760-928-90	60760-928	60760-0928-90	90 TABLET in 1 BOTTLE, PLASTIC (60760-928-90)
25 mg/1	62584-265-01	62584-265	62584-0265-01	100 BLISTER PACK in 1 BOX, UNIT-DOSE (62584-265-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (62584-265-11)
Inner component	62584-265-11	62584-265	62584-0265-11	Inner component of kit (62584-265-01)
50 mg/1	62584-266-01	62584-266	62584-0266-01	100 BLISTER PACK in 1 BOX, UNIT-DOSE (62584-266-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (62584-266-11)
Inner component	62584-266-11	62584-266	62584-0266-11	Inner component of kit (62584-266-01)
100 mg/1	62584-267-01	62584-267	62584-0267-01	100 BLISTER PACK in 1 BOX, UNIT-DOSE (62584-267-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (62584-267-11)
Inner component	62584-267-11	62584-267	62584-0267-11	Inner component of kit (62584-267-01)
100 mg/1	50090-2260-0	50090-2260	50090-2260-00	30 TABLET, FILM COATED in 1 BOTTLE (50090-2260-0)
100 mg/1	50090-2260-1	50090-2260	50090-2260-01	60 TABLET, FILM COATED in 1 BOTTLE (50090-2260-1)
100 mg/1	50090-2260-3	50090-2260	50090-2260-03	90 TABLET, FILM COATED in 1 BOTTLE (50090-2260-3)
100 mg/1	50090-2260-4	50090-2260	50090-2260-04	180 TABLET, FILM COATED in 1 BOTTLE (50090-2260-4)
50 mg/1	60760-944-60	60760-944	60760-0944-60	60 TABLET in 1 BOTTLE, PLASTIC (60760-944-60)
100 mg/1	50090-7488-0	50090-7488	50090-7488-00	90 TABLET, FILM COATED in 1 BOTTLE (50090-7488-0)
5 mg/5mL	51662-1365-1	51662-1365	51662-1365-01	5 mL in 1 VIAL (51662-1365-1)
100 mg/1	63187-532-30	63187-532	63187-0532-30	30 TABLET, FILM COATED in 1 BOTTLE (63187-532-30)
100 mg/1	63187-532-60	63187-532	63187-0532-60	60 TABLET, FILM COATED in 1 BOTTLE (63187-532-60)
100 mg/1	63187-532-72	63187-532	63187-0532-72	120 TABLET, FILM COATED in 1 BOTTLE (63187-532-72)
100 mg/1	63187-532-78	63187-532	63187-0532-78	180 TABLET, FILM COATED in 1 BOTTLE (63187-532-78)
100 mg/1	63187-532-90	63187-532	63187-0532-90	90 TABLET, FILM COATED in 1 BOTTLE (63187-532-90)
50 mg/1	70518-4418-0	70518-4418	70518-4418-00	30 TABLET in 1 BLISTER PACK (70518-4418-0)
50 mg/1	70518-4418-1	70518-4418	70518-4418-01	90 TABLET in 1 BOTTLE, PLASTIC (70518-4418-1)
50 mg/1	70518-4418-2	70518-4418	70518-4418-02	30 TABLET in 1 BLISTER PACK (70518-4418-2)
50 mg/1	70518-4418-3	70518-4418	70518-4418-03	50 POUCH in 1 BOX (70518-4418-3) / 1 TABLET in 1 POUCH (70518-4418-4)
Inner component	70518-4418-4	70518-4418	70518-4418-04	Inner component of kit (70518-4418-3)
50 mg/1	70518-4418-5	70518-4418	70518-4418-05	180 TABLET in 1 BOTTLE, PLASTIC (70518-4418-5)
1 mg/mL	0409-2016-10	0409-2016	00409-2016-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0409-2016-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-2016-05)
Vial component	0409-2016-05	0409-2016	00409-2016-05	Inner component of kit (0409-2016-10)
25 mg/1	71335-9745-1	71335-9745	71335-9745-01	30 TABLET, FILM COATED in 1 BOTTLE (71335-9745-1)
25 mg/1	71335-9745-2	71335-9745	71335-9745-02	60 TABLET, FILM COATED in 1 BOTTLE (71335-9745-2)
25 mg/1	71335-9745-3	71335-9745	71335-9745-03	90 TABLET, FILM COATED in 1 BOTTLE (71335-9745-3)
25 mg/1	71335-9745-4	71335-9745	71335-9745-04	180 TABLET, FILM COATED in 1 BOTTLE (71335-9745-4)
25 mg/1	71335-9745-5	71335-9745	71335-9745-05	100 TABLET, FILM COATED in 1 BOTTLE (71335-9745-5)
25 mg/1	71335-9745-6	71335-9745	71335-9745-06	120 TABLET, FILM COATED in 1 BOTTLE (71335-9745-6)
25 mg/1	71335-9745-7	71335-9745	71335-9745-07	20 TABLET, FILM COATED in 1 BOTTLE (71335-9745-7)
25 mg/1	71335-9745-8	71335-9745	71335-9745-08	10 TABLET, FILM COATED in 1 BOTTLE (71335-9745-8)
100 mg/1	76420-954-00	76420-954	76420-0954-00	1000 TABLET, FILM COATED in 1 BOTTLE (76420-954-00)
100 mg/1	76420-954-01	76420-954	76420-0954-01	100 TABLET, FILM COATED in 1 BOTTLE (76420-954-01)
100 mg/1	76420-954-20	76420-954	76420-0954-20	20 TABLET, FILM COATED in 1 BOTTLE (76420-954-20)
100 mg/1	76420-954-30	76420-954	76420-0954-30	30 TABLET, FILM COATED in 1 BOTTLE (76420-954-30)
100 mg/1	76420-954-60	76420-954	76420-0954-60	60 TABLET, FILM COATED in 1 BOTTLE (76420-954-60)
100 mg/1	76420-954-90	76420-954	76420-0954-90	90 TABLET, FILM COATED in 1 BOTTLE (76420-954-90)
50 mg/1	67296-2322-3	67296-2322	67296-2322-03	30 TABLET in 1 BOTTLE (67296-2322-3)
50 mg/1	67296-2322-6	67296-2322	67296-2322-06	60 TABLET in 1 BOTTLE (67296-2322-6)
5 mg/5mL	72572-420-10	72572-420	72572-0420-10	10 VIAL in 1 CARTON (72572-420-10) / 5 mL in 1 VIAL (72572-420-01)
Vial component	72572-420-01	72572-420	72572-0420-01	Inner component of kit (72572-420-10)
25 mg/1	67296-2323-6	67296-2323	67296-2323-06	60 TABLET in 1 BOTTLE (67296-2323-6)
50 mg/1, 25 mg/1	27241-301-01	27241-301	27241-0301-01	100 TABLET in 1 BOTTLE (27241-301-01)
100 mg/1, 25 mg/1	27241-302-01	27241-302	27241-0302-01	100 TABLET in 1 BOTTLE (27241-302-01)
25 mg/1	51079-255-20	51079-255	51079-0255-20	100 BLISTER PACK in 1 CARTON (51079-255-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-255-01)
Inner component	51079-255-01	51079-255	51079-0255-01	Inner component of kit (51079-255-20)
12.5 mg/1	72888-197-00	72888-197	72888-0197-00	1000 TABLET in 1 BOTTLE (72888-197-00)
12.5 mg/1	72888-197-03	72888-197	72888-0197-03	60 TABLET in 1 BOTTLE (72888-197-03)
12.5 mg/1	72888-197-30	72888-197	72888-0197-30	30 TABLET in 1 BOTTLE (72888-197-30)
50 mg/1	82804-165-90	82804-165	82804-0165-90	90 TABLET, FILM COATED in 1 BOTTLE (82804-165-90)
25 mg/1	67296-1903-6	67296-1903	67296-1903-06	60 TABLET, FILM COATED in 1 BOTTLE (67296-1903-6)
25 mg/1	67296-1903-1	67296-1903	67296-1903-01	180 TABLET, FILM COATED in 1 BOTTLE (67296-1903-1)
25 mg/1	67296-1903-3	67296-1903	67296-1903-03	30 TABLET, FILM COATED in 1 BOTTLE (67296-1903-3)
25 mg/1	67296-1903-9	67296-1903	67296-1903-09	90 TABLET, FILM COATED in 1 BOTTLE (67296-1903-9)
25 mg/1	72888-208-00	72888-208	72888-0208-00	1000 TABLET in 1 BOTTLE (72888-208-00)
25 mg/1	72888-208-01	72888-208	72888-0208-01	100 TABLET in 1 BOTTLE (72888-208-01)
25 mg/1	72888-208-02	72888-208	72888-0208-02	10000 TABLET in 1 POUCH (72888-208-02)
25 mg/1	72888-208-05	72888-208	72888-0208-05	500 TABLET in 1 BOTTLE (72888-208-05)
37.5 mg/1	72888-209-01	72888-209	72888-0209-01	100 TABLET in 1 BOTTLE (72888-209-01)
37.5 mg/1	72888-209-05	72888-209	72888-0209-05	500 TABLET in 1 BOTTLE (72888-209-05)
50 mg/1	72888-210-00	72888-210	72888-0210-00	1000 TABLET in 1 BOTTLE (72888-210-00)
50 mg/1	72888-210-01	72888-210	72888-0210-01	100 TABLET in 1 BOTTLE (72888-210-01)
50 mg/1	72888-210-02	72888-210	72888-0210-02	5000 TABLET in 1 POUCH (72888-210-02)
50 mg/1	72888-210-05	72888-210	72888-0210-05	500 TABLET in 1 BOTTLE (72888-210-05)
50 mg/1	60760-524-60	60760-524	60760-0524-60	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-524-60)
50 mg/1	60760-524-98	60760-524	60760-0524-98	180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-524-98)

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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