NDC 65862-501OTC monographFDA DRUG FOR FURTHER PROCESSING

Generic formulation

Active substance: Amoxicillin and Clavulanate Potassium

50 formulations • 109 package configurations

All 159 registered NDCs — click to copy

In one line

Generic formulation (Amoxicillin and Clavulanate Potassium) NDC 65862-501 converts to 65862-0501-15 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: 65862-501 Verified

1. Initial Approval

2023

First U.S. FDA clearance for Amoxicillin and Clavulanate Potassium

2. FDA Application

DRUG FOR FURTHER PROCESSING

Regulatory pathway: DRUG FOR FURTHER PROCESSING

3. Market Entry Date

Jan 20, 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

65862-0501-15

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
600 mg/5mL, 42.9 mg/5mL	73043-008-01	73043-008	73043-0008-01	75 mL in 1 BOTTLE (73043-008-01)
600 mg/5mL, 42.9 mg/5mL	73043-008-02	73043-008	73043-0008-02	125 mL in 1 BOTTLE (73043-008-02)
600 mg/5mL, 42.9 mg/5mL	73043-008-03	73043-008	73043-0008-03	200 mL in 1 BOTTLE (73043-008-03)
875 mg/1, 125 mg/1	70518-4424-0	70518-4424	70518-4424-00	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4424-0)
875 mg/1, 125 mg/1	72789-459-03	72789-459	72789-0459-03	3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-459-03)
875 mg/1, 125 mg/1	72789-459-14	72789-459	72789-0459-14	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-459-14)
400 mg/5mL, 57 mg/5mL	73043-009-01	73043-009	73043-0009-01	50 mL in 1 BOTTLE (73043-009-01)
400 mg/5mL, 57 mg/5mL	73043-009-02	73043-009	73043-0009-02	75 mL in 1 BOTTLE (73043-009-02)
400 mg/5mL, 57 mg/5mL	73043-009-03	73043-009	73043-0009-03	100 mL in 1 BOTTLE (73043-009-03)
250 mg/5mL, 62.5 mg/5mL	73043-010-01	73043-010	73043-0010-01	75 mL in 1 BOTTLE (73043-010-01)
250 mg/5mL, 62.5 mg/5mL	73043-010-02	73043-010	73043-0010-02	100 mL in 1 BOTTLE (73043-010-02)
250 mg/5mL, 62.5 mg/5mL	73043-010-03	73043-010	73043-0010-03	150 mL in 1 BOTTLE (73043-010-03)
600 mg/5mL, 42.9 mg/5mL	65862-535-02	65862-535	65862-0535-02	200 mL in 1 BOTTLE (65862-535-02)
600 mg/5mL, 42.9 mg/5mL	65862-535-13	65862-535	65862-0535-13	125 mL in 1 BOTTLE (65862-535-13)
600 mg/5mL, 42.9 mg/5mL	65862-535-75	65862-535	65862-0535-75	75 mL in 1 BOTTLE (65862-535-75)
875 mg/1, 125 mg/1	63187-488-14	63187-488	63187-0488-14	14 TABLET, FILM COATED in 1 BOTTLE (63187-488-14)
875 mg/1, 125 mg/1	63187-488-20	63187-488	63187-0488-20	20 TABLET, FILM COATED in 1 BOTTLE (63187-488-20)
875 mg/1, 125 mg/1	63187-488-28	63187-488	63187-0488-28	28 TABLET, FILM COATED in 1 BOTTLE (63187-488-28)
875 mg/1, 125 mg/1	63187-488-30	63187-488	63187-0488-30	30 TABLET, FILM COATED in 1 BOTTLE (63187-488-30)
875 mg/1, 125 mg/1	63187-488-40	63187-488	63187-0488-40	40 TABLET, FILM COATED in 1 BOTTLE (63187-488-40)
500 mg/1, 125 mg/1	85766-022-20	85766-022	85766-0022-20	20 TABLET, FILM COATED in 1 BOTTLE (85766-022-20)
875 mg/1, 125 mg/1	85766-268-01	85766-268	85766-0268-01	100 POUCH in 1 BOX (85766-268-01) / 1 TABLET, FILM COATED in 1 POUCH
875 mg/1, 125 mg/1	85766-268-03	85766-268	85766-0268-03	30 TABLET, FILM COATED in 1 BLISTER PACK (85766-268-03)
875 mg/1, 125 mg/1	85766-268-10	85766-268	85766-0268-10	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-268-10)
875 mg/1, 125 mg/1	85766-268-14	85766-268	85766-0268-14	14 TABLET, FILM COATED in 1 BLISTER PACK (85766-268-14)
875 mg/1, 125 mg/1	85766-268-20	85766-268	85766-0268-20	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-268-20)
875 mg/1, 125 mg/1	85766-268-30	85766-268	85766-0268-30	30 TABLET, FILM COATED in 1 BLISTER PACK (85766-268-30)
500 mg/1, 125 mg/1	72789-418-14	72789-418	72789-0418-14	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-418-14)
500 mg/1, 125 mg/1	63187-032-06	63187-032	63187-0032-06	6 TABLET, FILM COATED in 1 BOTTLE (63187-032-06)
500 mg/1, 125 mg/1	63187-032-20	63187-032	63187-0032-20	20 TABLET, FILM COATED in 1 BOTTLE (63187-032-20)
500 mg/1, 125 mg/1	63187-032-21	63187-032	63187-0032-21	21 TABLET, FILM COATED in 1 BOTTLE (63187-032-21)
875 mg/1, 125 mg/1	67046-0955-3	67046-0955	67046-0955-03	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0955-3)
875 mg/1, 125 mg/1	72789-421-14	72789-421	72789-0421-14	14 TABLET in 1 BOTTLE, PLASTIC (72789-421-14)
600 mg/5mL, 42.9 mg/5mL	0143-9853-16	0143-9853	00143-9853-16	125 mL in 1 BOTTLE (0143-9853-16)
600 mg/5mL, 42.9 mg/5mL	0143-9853-24	0143-9853	00143-9853-24	200 mL in 1 BOTTLE (0143-9853-24)
600 mg/5mL, 42.9 mg/5mL	0143-9853-75	0143-9853	00143-9853-75	75 mL in 1 BOTTLE (0143-9853-75)
875 mg/1, 125 mg/1	55289-767-10	55289-767	55289-0767-10	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-10)
875 mg/1, 125 mg/1	55289-767-14	55289-767	55289-0767-14	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-14)
875 mg/1, 125 mg/1	55289-767-20	55289-767	55289-0767-20	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-20)
875 mg/1, 125 mg/1	55289-767-21	55289-767	55289-0767-21	21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-21)
875 mg/1, 125 mg/1	55289-767-28	55289-767	55289-0767-28	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-28)
875 mg/1, 125 mg/1	55289-767-30	55289-767	55289-0767-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-30)
875 mg/1, 125 mg/1	43063-377-02	43063-377	43063-0377-02	2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-377-02)
500 mg/1, 125 mg/1	55289-845-06	55289-845	55289-0845-06	6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-06)
500 mg/1, 125 mg/1	55289-845-20	55289-845	55289-0845-20	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-20)
500 mg/1, 125 mg/1	55289-845-21	55289-845	55289-0845-21	21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-21)
500 mg/1, 125 mg/1	55289-845-28	55289-845	55289-0845-28	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-28)
500 mg/1, 125 mg/1	55289-845-30	55289-845	55289-0845-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-30)
600 mg/5mL, 42.9 mg/5mL	63187-857-12	63187-857	63187-0857-12	125 mL in 1 BOTTLE (63187-857-12)
600 mg/5mL, 42.9 mg/5mL	63187-857-20	63187-857	63187-0857-20	200 mL in 1 BOTTLE (63187-857-20)
600 mg/5mL, 42.9 mg/5mL	63187-857-75	63187-857	63187-0857-75	75 mL in 1 BOTTLE (63187-857-75)
875 mg/1, 125 mg/1	76420-607-01	76420-607	76420-0607-01	100 TABLET, FILM COATED in 1 BOTTLE (76420-607-01)
875 mg/1, 125 mg/1	76420-607-20	76420-607	76420-0607-20	20 TABLET, FILM COATED in 1 BOTTLE (76420-607-20)
500 mg/1, 125 mg/1	76420-608-20	76420-608	76420-0608-20	20 TABLET, FILM COATED in 1 BOTTLE (76420-608-20)
125 mg/1, 875 mg/1	80425-0180-1	80425-0180	80425-0180-01	20 TABLET, FILM COATED in 1 BOTTLE (80425-0180-1)
125 mg/1, 875 mg/1	80425-0180-2	80425-0180	80425-0180-02	30 TABLET, FILM COATED in 1 BOTTLE (80425-0180-2)
125 mg/1, 875 mg/1	80425-0180-3	80425-0180	80425-0180-03	14 TABLET, FILM COATED in 1 BOTTLE (80425-0180-3)
400 mg/5mL, 57 mg/5mL	68071-2518-1	68071-2518	68071-2518-01	100 mL in 1 BOTTLE (68071-2518-1)
600 mg/5mL, 42.9 mg/5mL	50090-2219-0	50090-2219	50090-2219-00	125 mL in 1 BOTTLE (50090-2219-0)
875 mg/1, 125 mg/1	70518-4148-0	70518-4148	70518-4148-00	100 POUCH in 1 BOX (70518-4148-0) / 1 TABLET in 1 POUCH (70518-4148-1)
Inner component	70518-4148-1	70518-4148	70518-4148-01	Inner component of kit (70518-4148-0)
875 mg/1, 125 mg/1	70518-4148-2	70518-4148	70518-4148-02	20 TABLET in 1 BLISTER PACK (70518-4148-2)
875 mg/1, 125 mg/1	70518-4148-3	70518-4148	70518-4148-03	30 TABLET in 1 BLISTER PACK (70518-4148-3)
875 mg/1, 125 mg/1	70518-4148-4	70518-4148	70518-4148-04	14 TABLET in 1 BLISTER PACK (70518-4148-4)
500 mg/1, 125 mg/1	72189-281-14	72189-281	72189-0281-14	14 TABLET, FILM COATED in 1 BOTTLE (72189-281-14)
500 mg/1, 125 mg/1	72189-281-20	72189-281	72189-0281-20	20 TABLET, FILM COATED in 1 BOTTLE (72189-281-20)
875 mg/1, 125 mg/1	70518-3604-3	70518-3604	70518-3604-03	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3604-3)
875 mg/1, 125 mg/1	70518-3604-4	70518-3604	70518-3604-04	20 TABLET, FILM COATED in 1 BLISTER PACK (70518-3604-4)
600 mg/5mL, 42.9 mg/5mL	68071-3774-5	68071-3774	68071-3774-05	125 mL in 1 BOTTLE (68071-3774-5)
250 mg/5mL, 62.5 mg/5mL	69097-098-08	69097-098	69097-0098-08	150 mL in 1 BOTTLE (69097-098-08)
250 mg/5mL, 62.5 mg/5mL	69097-098-43	69097-098	69097-0098-43	75 mL in 1 BOTTLE (69097-098-43)
250 mg/5mL, 62.5 mg/5mL	69097-098-44	69097-098	69097-0098-44	100 mL in 1 BOTTLE (69097-098-44)
500 mg/1, 125 mg/1	71335-2824-1	71335-2824	71335-2824-01	20 TABLET, FILM COATED in 1 BOTTLE (71335-2824-1)
875 mg/1, 125 mg/1	70518-3624-2	70518-3624	70518-3624-02	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3624-2)
875 mg/1, 125 mg/1	70518-3624-4	70518-3624	70518-3624-04	100 POUCH in 1 BOX (70518-3624-4) / 1 TABLET, FILM COATED in 1 POUCH (70518-3624-5)
Inner component	70518-3624-5	70518-3624	70518-3624-05	Inner component of kit (70518-3624-4)
875 mg/1, 125 mg/1	73043-006-20	73043-006	73043-0006-20	20 TABLET, FILM COATED in 1 BOTTLE (73043-006-20)
200 mg/5mL, 28.5 mg/5mL	0781-6102-46	0781-6102	00781-6102-46	100 mL in 1 BOTTLE (0781-6102-46)
200 mg/5mL, 28.5 mg/5mL	0781-6102-52	0781-6102	00781-6102-52	50 mL in 1 BOTTLE (0781-6102-52)
200 mg/5mL, 28.5 mg/5mL	0781-6102-57	0781-6102	00781-6102-57	75 mL in 1 BOTTLE (0781-6102-57)
875 mg/1, 125 mg/1	72789-456-14	72789-456	72789-0456-14	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-456-14)
500 mg/1, 125 mg/1	73043-007-20	73043-007	73043-0007-20	20 TABLET, FILM COATED in 1 BOTTLE (73043-007-20)
875 mg/1, 125 mg/1	68071-4967-2	68071-4967	68071-4967-02	20 TABLET in 1 BOTTLE (68071-4967-2)
875 mg/1, 125 mg/1	82868-002-10	82868-002	82868-0002-10	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-002-10)
875 mg/1, 125 mg/1	82868-002-14	82868-002	82868-0002-14	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-002-14)
400 mg/5mL, 57 mg/5mL	0781-6104-46	0781-6104	00781-6104-46	100 mL in 1 BOTTLE (0781-6104-46)
400 mg/5mL, 57 mg/5mL	0781-6104-52	0781-6104	00781-6104-52	50 mL in 1 BOTTLE (0781-6104-52)
400 mg/5mL, 57 mg/5mL	0781-6104-57	0781-6104	00781-6104-57	75 mL in 1 BOTTLE (0781-6104-57)
400 mg/5mL, 57 mg/5mL	68071-1619-1	68071-1619	68071-1619-01	100 mL in 1 BOTTLE (68071-1619-1)
200 mg/5mL, 28.5 mg/5mL	16714-292-01	16714-292	16714-0292-01	50 mL in 1 BOTTLE (16714-292-01)
200 mg/5mL, 28.5 mg/5mL	16714-292-02	16714-292	16714-0292-02	75 mL in 1 BOTTLE (16714-292-02)
200 mg/5mL, 28.5 mg/5mL	16714-292-03	16714-292	16714-0292-03	100 mL in 1 BOTTLE (16714-292-03)
875 mg/1, 125 mg/1	68788-4158-2	68788-4158	68788-4158-02	20 TABLET, FILM COATED in 1 BOTTLE (68788-4158-2)
875 mg/1, 125 mg/1	70518-3676-2	70518-3676	70518-3676-02	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3676-2)
400 mg/5mL, 57 mg/5mL	16714-293-01	16714-293	16714-0293-01	50 mL in 1 BOTTLE (16714-293-01)
400 mg/5mL, 57 mg/5mL	16714-293-02	16714-293	16714-0293-02	75 mL in 1 BOTTLE (16714-293-02)
400 mg/5mL, 57 mg/5mL	16714-293-03	16714-293	16714-0293-03	100 mL in 1 BOTTLE (16714-293-03)
600 mg/5mL, 42.9 mg/5mL	16714-294-01	16714-294	16714-0294-01	75 mL in 1 BOTTLE (16714-294-01)
600 mg/5mL, 42.9 mg/5mL	16714-294-02	16714-294	16714-0294-02	125 mL in 1 BOTTLE (16714-294-02)
600 mg/5mL, 42.9 mg/5mL	16714-294-03	16714-294	16714-0294-03	200 mL in 1 BOTTLE (16714-294-03)
250 mg/1, 125 mg/1	16714-295-01	16714-295	16714-0295-01	30 TABLET, FILM COATED in 1 BOTTLE (16714-295-01)
500 mg/1, 125 mg/1	16714-296-01	16714-296	16714-0296-01	20 TABLET, FILM COATED in 1 BOTTLE (16714-296-01)
875 mg/1, 125 mg/1	16714-297-01	16714-297	16714-0297-01	20 TABLET, FILM COATED in 1 BOTTLE (16714-297-01)
875 mg/1, 125 mg/1	16714-297-02	16714-297	16714-0297-02	100 TABLET, FILM COATED in 1 BOTTLE (16714-297-02)
200 mg/5mL, 28.5 mg/5mL	68071-3807-1	68071-3807	68071-3807-01	100 mL in 1 BOTTLE (68071-3807-1)
500 mg/1, 125 mg/1	68071-4275-2	68071-4275	68071-4275-02	20 TABLET, FILM COATED in 1 BOTTLE (68071-4275-2)
875 mg/1, 125 mg/1	85766-078-01	85766-078	85766-0078-01	100 TABLET, FILM COATED in 1 BOTTLE (85766-078-01)
875 mg/1, 125 mg/1	85766-078-20	85766-078	85766-0078-20	20 TABLET, FILM COATED in 1 BOTTLE (85766-078-20)
500 mg/1, 125 mg/1	85766-079-20	85766-079	85766-0079-20	20 TABLET, FILM COATED in 1 BOTTLE (85766-079-20)

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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NDC • HCPCS Level II • CPT administration

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