NDC 12578-608OTC monographFDA BULK INGREDIENT

Generic formulation

Active substance: Buprenorphine Hydrochloride

36 formulations • 65 package configurations

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Generic formulation (Buprenorphine Hydrochloride) NDC 12578-608 converts to 12578-0608-00 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: 12578-608

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

12578-0608-00

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, .5 mg/1	87441-003-01	87441-003	87441-0003-01	30 TABLET in 1 BLISTER PACK (87441-003-01)
2 mg/1, .5 mg/1	16729-549-10	16729-549	16729-0549-10	30 TABLET in 1 BOTTLE, PLASTIC (16729-549-10)
8 mg/1, 2 mg/1	16729-550-10	16729-550	16729-0550-10	30 TABLET in 1 BOTTLE, PLASTIC (16729-550-10)
.324 mg/mL	42023-179-05	42023-179	42023-0179-05	5 VIAL in 1 CARTON (42023-179-05) / 1 mL in 1 VIAL
8 mg/1	50090-7559-0	50090-7559	50090-7559-00	30 TABLET in 1 BOTTLE (50090-7559-0)
.5 mg/1, 2 mg/1	51407-948-30	51407-948	51407-0948-30	30 TABLET in 1 BOTTLE (51407-948-30)
8 mg/1, 2 mg/1	51407-949-30	51407-949	51407-0949-30	30 TABLET in 1 BOTTLE (51407-949-30)
2 mg/1, .5 mg/1	70518-3862-0	70518-3862	70518-3862-00	30 TABLET in 1 BLISTER PACK (70518-3862-0)
8 mg/1	0121-2038-30	0121-2038	00121-2038-30	30 TABLET in 1 BOTTLE (0121-2038-30)
8 mg/1, 2 mg/1	76420-534-30	76420-534	76420-0534-30	30 TABLET in 1 BOTTLE, PLASTIC (76420-534-30)
2 mg/1, .5 mg/1	0904-7009-06	0904-7009	00904-7009-06	50 BLISTER PACK in 1 CARTON (0904-7009-06) / 1 TABLET in 1 BLISTER PACK
8 mg/1, 2 mg/1	0904-7010-06	0904-7010	00904-7010-06	50 BLISTER PACK in 1 CARTON (0904-7010-06) / 1 TABLET in 1 BLISTER PACK
8 mg/1, 2 mg/1	67296-2191-1	67296-2191	67296-2191-01	12 TABLET in 1 BOTTLE, PLASTIC (67296-2191-1)
8 mg/1, 2 mg/1	67296-2191-6	67296-2191	67296-2191-06	6 TABLET in 1 BOTTLE, PLASTIC (67296-2191-6)
2 mg/1	70518-4570-0	70518-4570	70518-4570-00	30 POUCH in 1 BOX (70518-4570-0) / 1 TABLET in 1 POUCH (70518-4570-1)
Inner component	70518-4570-1	70518-4570	70518-4570-01	Inner component of kit (70518-4570-0)
8 mg/1	70518-4571-0	70518-4571	70518-4571-00	30 POUCH in 1 BOX (70518-4571-0) / 1 TABLET in 1 POUCH (70518-4571-1)
Inner component	70518-4571-1	70518-4571	70518-4571-01	Inner component of kit (70518-4571-0)
8 mg/1	70518-4571-2	70518-4571	70518-4571-02	50 POUCH in 1 BOX (70518-4571-2) / 1 TABLET in 1 POUCH (70518-4571-1)
2 mg/1, .5 mg/1	58118-0549-8	58118-0549	58118-0549-08	30 TABLET in 1 BLISTER PACK (58118-0549-8)
2 mg/1, .5 mg/1	71335-1653-1	71335-1653	71335-1653-01	30 TABLET in 1 BOTTLE (71335-1653-1)
.3 mg/mL	0409-2012-32	0409-2012	00409-2012-32	10 CARTRIDGE in 1 CARTON (0409-2012-32) / 1 mL in 1 CARTRIDGE (0409-2012-03)
Inner component	0409-2012-03	0409-2012	00409-2012-03	Inner component of kit (0409-2012-32)
.324 mg/mL	0143-9246-05	0143-9246	00143-9246-05	5 VIAL in 1 CARTON (0143-9246-05) / 1 mL in 1 VIAL (0143-9246-01)
Vial component	0143-9246-01	0143-9246	00143-9246-01	Inner component of kit (0143-9246-05)
8 mg/1, 2 mg/1	71335-1858-0	71335-1858	71335-1858-00	42 TABLET in 1 BOTTLE, PLASTIC (71335-1858-0)
8 mg/1, 2 mg/1	71335-1858-1	71335-1858	71335-1858-01	30 TABLET in 1 BOTTLE, PLASTIC (71335-1858-1)
8 mg/1, 2 mg/1	71335-1858-2	71335-1858	71335-1858-02	60 TABLET in 1 BOTTLE, PLASTIC (71335-1858-2)
8 mg/1, 2 mg/1	71335-1858-3	71335-1858	71335-1858-03	90 TABLET in 1 BOTTLE, PLASTIC (71335-1858-3)
8 mg/1, 2 mg/1	71335-1858-4	71335-1858	71335-1858-04	120 TABLET in 1 BOTTLE, PLASTIC (71335-1858-4)
8 mg/1, 2 mg/1	71335-1858-5	71335-1858	71335-1858-05	14 TABLET in 1 BOTTLE, PLASTIC (71335-1858-5)
8 mg/1, 2 mg/1	71335-1858-6	71335-1858	71335-1858-06	28 TABLET in 1 BOTTLE, PLASTIC (71335-1858-6)
8 mg/1, 2 mg/1	71335-1858-7	71335-1858	71335-1858-07	6 TABLET in 1 BOTTLE, PLASTIC (71335-1858-7)
8 mg/1, 2 mg/1	71335-1858-8	71335-1858	71335-1858-08	10 TABLET in 1 BOTTLE, PLASTIC (71335-1858-8)
8 mg/1, 2 mg/1	71335-1858-9	71335-1858	71335-1858-09	21 TABLET in 1 BOTTLE, PLASTIC (71335-1858-9)
8 mg/1, 2 mg/1	70518-3844-0	70518-3844	70518-3844-00	30 TABLET in 1 BLISTER PACK (70518-3844-0)
2 mg/1, .5 mg/1	58118-1188-8	58118-1188	58118-1188-08	30 TABLET in 1 BLISTER PACK (58118-1188-8)
8 mg/1, 2 mg/1	58118-1189-8	58118-1189	58118-1189-08	30 TABLET in 1 BLISTER PACK (58118-1189-8)
2 mg/1	72888-182-30	72888-182	72888-0182-30	30 TABLET in 1 BOTTLE (72888-182-30)
2 mg/1	72888-182-90	72888-182	72888-0182-90	90 TABLET in 1 BOTTLE (72888-182-90)
8 mg/1	72888-183-30	72888-183	72888-0183-30	30 TABLET in 1 BOTTLE (72888-183-30)
8 mg/1	72888-183-90	72888-183	72888-0183-90	90 TABLET in 1 BOTTLE (72888-183-90)
2 mg/1, .5 mg/1	58118-8005-8	58118-8005	58118-8005-08	30 TABLET in 1 BLISTER PACK (58118-8005-8)
8 mg/1, 2 mg/1	58118-8020-8	58118-8020	58118-8020-08	30 TABLET in 1 BLISTER PACK (58118-8020-8)
2 mg/1, .5 mg/1	0406-8005-03	0406-8005	00406-8005-03	30 TABLET in 1 BOTTLE, PLASTIC (0406-8005-03)
2 mg/1, .5 mg/1	71335-1720-1	71335-1720	71335-1720-01	30 TABLET in 1 BOTTLE (71335-1720-1)
2 mg/1, .5 mg/1	71335-1720-2	71335-1720	71335-1720-02	10 TABLET in 1 BOTTLE (71335-1720-2)
.324 mg/mL	70069-027-05	70069-027	70069-0027-05	5 VIAL in 1 CARTON (70069-027-05) / 1 mL in 1 VIAL
8 mg/1, 2 mg/1	71335-1725-0	71335-1725	71335-1725-00	42 TABLET in 1 BOTTLE (71335-1725-0)
8 mg/1, 2 mg/1	71335-1725-1	71335-1725	71335-1725-01	30 TABLET in 1 BOTTLE (71335-1725-1)
8 mg/1, 2 mg/1	71335-1725-2	71335-1725	71335-1725-02	60 TABLET in 1 BOTTLE (71335-1725-2)
8 mg/1, 2 mg/1	71335-1725-3	71335-1725	71335-1725-03	90 TABLET in 1 BOTTLE (71335-1725-3)
8 mg/1, 2 mg/1	71335-1725-4	71335-1725	71335-1725-04	120 TABLET in 1 BOTTLE (71335-1725-4)
8 mg/1, 2 mg/1	71335-1725-5	71335-1725	71335-1725-05	14 TABLET in 1 BOTTLE, PLASTIC (71335-1725-5)
8 mg/1, 2 mg/1	71335-1725-6	71335-1725	71335-1725-06	28 TABLET in 1 BOTTLE, PLASTIC (71335-1725-6)
8 mg/1, 2 mg/1	71335-1725-7	71335-1725	71335-1725-07	6 TABLET in 1 BOTTLE, PLASTIC (71335-1725-7)
8 mg/1, 2 mg/1	71335-1725-8	71335-1725	71335-1725-08	10 TABLET in 1 BOTTLE, PLASTIC (71335-1725-8)
8 mg/1, 2 mg/1	71335-1725-9	71335-1725	71335-1725-09	21 TABLET in 1 BOTTLE, PLASTIC (71335-1725-9)
8 mg/1, 2 mg/1	0406-8020-03	0406-8020	00406-8020-03	30 TABLET in 1 BOTTLE, PLASTIC (0406-8020-03)
2 mg/1	0121-1019-30	0121-1019	00121-1019-30	30 TABLET in 1 BOTTLE (0121-1019-30)
4 mg/1	72888-509-01	72888-509	72888-0509-01	30 TABLET in 1 BOTTLE (72888-509-01)
4 mg/1	72888-509-02	72888-509	72888-0509-02	90 TABLET in 1 BOTTLE (72888-509-02)
12 mg/1	72888-510-01	72888-510	72888-0510-01	30 TABLET in 1 BOTTLE (72888-510-01)
12 mg/1	72888-510-02	72888-510	72888-0510-02	90 TABLET in 1 BOTTLE (72888-510-02)
8 mg/1, 2 mg/1	87441-002-01	87441-002	87441-0002-01	30 TABLET in 1 BLISTER PACK (87441-002-01)

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

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Highlights

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