NDC 63415-0070OTC monographFDA BULK INGREDIENT

Generic formulation

Active substance: Desmopressin Acetate

FDA labeler: Assia Chemical Industries Ltd - Teva Tech Site

50 formulations • 70 package configurations

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Generic formulation (Desmopressin Acetate) NDC 63415-0070 converts to 63415-0070-00 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: 63415-0070

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

63415-0070-00

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
4 ug/mL	83148-126-01	83148-126	83148-0126-01	1 VIAL in 1 CARTON (83148-126-01) / 10 mL in 1 VIAL
.2 mg/1	63629-3257-1	63629-3257	63629-3257-01	90 TABLET in 1 BOTTLE (63629-3257-1)
.2 mg/1	51655-461-52	51655-461	51655-0461-52	30 TABLET in 1 BOTTLE, PLASTIC (51655-461-52)
4 ug/mL	39822-6200-2	39822-6200	39822-6200-02	10 VIAL in 1 CARTON (39822-6200-2) / 1 mL in 1 VIAL (39822-6200-1)
Vial component	39822-6200-1	39822-6200	39822-6200-01	Inner component of kit (39822-6200-2)
4 ug/mL	39822-6250-1	39822-6250	39822-6250-01	1 VIAL in 1 CARTON (39822-6250-1) / 10 mL in 1 VIAL
4 ug/mL	65219-293-01	65219-293	65219-0293-01	10 VIAL, SINGLE-DOSE in 1 CARTON (65219-293-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-293-00)
Vial component	65219-293-00	65219-293	65219-0293-00	Inner component of kit (65219-293-01)
4 ug/mL	65219-295-10	65219-295	65219-0295-10	1 VIAL, MULTI-DOSE in 1 CARTON (65219-295-10) / 10 mL in 1 VIAL, MULTI-DOSE
4 ug/mL	83634-451-01	83634-451	83634-0451-01	10 VIAL in 1 CARTON (83634-451-01) / 1 mL in 1 VIAL (83634-451-41)
Vial component	83634-451-41	83634-451	83634-0451-41	Inner component of kit (83634-451-01)
4 ug/mL	83634-451-10	83634-451	83634-0451-10	1 VIAL in 1 CARTON (83634-451-10) / 10 mL in 1 VIAL
.1 mg/1	68001-574-00	68001-574	68001-0574-00	100 TABLET in 1 BOTTLE (68001-574-00)
.2 mg/1	68001-575-00	68001-575	68001-0575-00	100 TABLET in 1 BOTTLE (68001-575-00)
.1 mg/1	10702-169-01	10702-169	10702-0169-01	100 TABLET in 1 BOTTLE (10702-169-01)
4 ug/mL	43598-931-09	43598-931	43598-0931-09	10 AMPULE in 1 BOX (43598-931-09) / 1 mL in 1 AMPULE
.2 mg/1	10702-170-01	10702-170	10702-0170-01	100 TABLET in 1 BOTTLE (10702-170-01)
4 ug/mL	65145-183-10	65145-183	65145-0183-10	10 VIAL, SINGLE-DOSE in 1 CARTON (65145-183-10) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-183-01)
Vial component	65145-183-01	65145-183	65145-0183-01	Inner component of kit (65145-183-10)
4 ug/mL	65145-184-01	65145-184	65145-0184-01	1 VIAL, MULTI-DOSE in 1 CARTON (65145-184-01) / 10 mL in 1 VIAL, MULTI-DOSE
.1 mg/1	23155-489-01	23155-489	23155-0489-01	100 TABLET in 1 BOTTLE (23155-489-01)
.1 mg/1	23155-489-05	23155-489	23155-0489-05	500 TABLET in 1 BOTTLE (23155-489-05)
.2 mg/1	23155-490-01	23155-490	23155-0490-01	100 TABLET in 1 BOTTLE (23155-490-01)
.2 mg/1	23155-490-05	23155-490	23155-0490-05	500 TABLET in 1 BOTTLE (23155-490-05)
.1 mg/1	68462-275-01	68462-275	68462-0275-01	100 TABLET in 1 BOTTLE (68462-275-01)
.1 mg/1	68462-275-10	68462-275	68462-0275-10	1000 TABLET in 1 BOTTLE (68462-275-10)
.1 mg/1	68462-275-30	68462-275	68462-0275-30	30 TABLET in 1 BOTTLE (68462-275-30)
.1 mg/1	68462-275-90	68462-275	68462-0275-90	90 TABLET in 1 BOTTLE (68462-275-90)
.2 mg/1	68462-276-01	68462-276	68462-0276-01	100 TABLET in 1 BOTTLE (68462-276-01)
.2 mg/1	68462-276-10	68462-276	68462-0276-10	1000 TABLET in 1 BOTTLE (68462-276-10)
.2 mg/1	68462-276-30	68462-276	68462-0276-30	30 TABLET in 1 BOTTLE (68462-276-30)
.2 mg/1	68462-276-90	68462-276	68462-0276-90	90 TABLET in 1 BOTTLE (68462-276-90)
.1 mg/mL	68682-342-05	68682-342	68682-0342-05	1 BOTTLE, PUMP in 1 CARTON (68682-342-05) / 5 mL in 1 BOTTLE, PUMP
4 ug/mL	70095-026-02	70095-026	70095-0026-02	10 VIAL, SINGLE-DOSE in 1 CARTON (70095-026-02) / 1 mL in 1 VIAL, SINGLE-DOSE (70095-026-01)
Vial component	70095-026-01	70095-026	70095-0026-01	Inner component of kit (70095-026-02)
4 ug/mL	62756-529-26	62756-529	62756-0529-26	1 VIAL, MULTI-DOSE in 1 CARTON (62756-529-26) / 10 mL in 1 VIAL, MULTI-DOSE
4 ug/mL	62756-529-40	62756-529	62756-0529-40	1 VIAL in 1 CARTON (62756-529-40) / 10 mL in 1 VIAL
.1 mg/mL	24208-342-05	24208-342	24208-0342-05	1 BOTTLE, PUMP in 1 CARTON (24208-342-05) / 5 mL in 1 BOTTLE, PUMP
.1 mg/1	60687-721-21	60687-721	60687-0721-21	30 BLISTER PACK in 1 CARTON (60687-721-21) / 1 TABLET in 1 BLISTER PACK (60687-721-11)
Inner component	60687-721-11	60687-721	60687-0721-11	Inner component of kit (60687-721-21)
4 ug/mL	70095-031-01	70095-031	70095-0031-01	1 VIAL in 1 CARTON (70095-031-01) / 10 mL in 1 VIAL
.1 mg/1	70518-4612-0	70518-4612	70518-4612-00	50 POUCH in 1 BOX (70518-4612-0) / 1 TABLET in 1 POUCH (70518-4612-1)
Inner component	70518-4612-1	70518-4612	70518-4612-01	Inner component of kit (70518-4612-0)
4 ug/mL	68083-549-01	68083-549	68083-0549-01	1 VIAL, MULTI-DOSE in 1 CARTON (68083-549-01) / 10 mL in 1 VIAL, MULTI-DOSE
4 ug/mL	68083-550-10	68083-550	68083-0550-10	10 VIAL, SINGLE-DOSE in 1 CARTON (68083-550-10) / 1 mL in 1 VIAL, SINGLE-DOSE (68083-550-01)
Vial component	68083-550-01	68083-550	68083-0550-01	Inner component of kit (68083-550-10)
40 ug/10mL	72485-524-01	72485-524	72485-0524-01	1 VIAL, MULTI-DOSE in 1 CARTON (72485-524-01) / 10 mL in 1 VIAL, MULTI-DOSE
.2 mg/1	60687-732-21	60687-732	60687-0732-21	30 BLISTER PACK in 1 CARTON (60687-732-21) / 1 TABLET in 1 BLISTER PACK (60687-732-11)
Inner component	60687-732-11	60687-732	60687-0732-11	Inner component of kit (60687-732-21)
4 ug/mL	72485-523-10	72485-523	72485-0523-10	10 VIAL, SINGLE-DOSE in 1 CARTON (72485-523-10) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-523-01)
Vial component	72485-523-01	72485-523	72485-0523-01	Inner component of kit (72485-523-10)
40 ug/10mL	25021-461-10	25021-461	25021-0461-10	1 VIAL in 1 CARTON (25021-461-10) / 10 mL in 1 VIAL
4 ug/mL	25021-460-01	25021-460	25021-0460-01	10 VIAL in 1 CARTON (25021-460-01) / 1 mL in 1 VIAL
.2 mg/1	69918-201-01	69918-201	69918-0201-01	1 BOTTLE in 1 CARTON (69918-201-01) / 100 TABLET in 1 BOTTLE
.1 mg/1	69918-101-01	69918-101	69918-0101-01	1 BOTTLE in 1 CARTON (69918-101-01) / 100 TABLET in 1 BOTTLE
40 ug/10mL	72843-440-01	72843-440	72843-0440-01	1 VIAL in 1 CARTON (72843-440-01) / 10 mL in 1 VIAL
4 ug/mL	72843-461-10	72843-461	72843-0461-10	10 VIAL in 1 CARTON (72843-461-10) / 1 mL in 1 VIAL
.1 mg/1	60505-0257-1	60505-0257	60505-0257-01	100 TABLET in 1 BOTTLE (60505-0257-1)
4 ug/mL	72843-459-10	72843-459	72843-0459-10	10 AMPULE in 1 BOX (72843-459-10) / 1 mL in 1 AMPULE
.2 mg/1	60505-0258-1	60505-0258	60505-0258-01	100 TABLET in 1 BOTTLE (60505-0258-1)
.2 mg/1	59651-250-01	59651-250	59651-0250-01	100 TABLET in 1 BOTTLE (59651-250-01)
.1 mg/1	59651-249-01	59651-249	59651-0249-01	100 TABLET in 1 BOTTLE (59651-249-01)
10 ug/1	60505-0815-0	60505-0815	60505-0815-00	1 BOTTLE, SPRAY in 1 CARTON (60505-0815-0) / 50 SPRAY in 1 BOTTLE, SPRAY
.2 mg/1	71335-2342-1	71335-2342	71335-2342-01	90 TABLET in 1 BOTTLE (71335-2342-1)
4 ug/mL	69918-901-10	69918-901	69918-0901-10	1 VIAL, MULTI-DOSE in 1 CARTON (69918-901-10) / 10 mL in 1 VIAL, MULTI-DOSE
4 ug/mL	69918-899-01	69918-899	69918-0899-01	1 mL in 1 AMPULE (69918-899-01)
4 ug/mL	69918-899-10	69918-899	69918-0899-10	10 AMPULE in 1 CARTON (69918-899-10) / 1 mL in 1 AMPULE
4 ug/mL	69918-899-11	69918-899	69918-0899-11	10 AMPULE in 1 CARTON (69918-899-11) / 1 mL in 1 AMPULE
4 ug/mL	69918-901-12	69918-901	69918-0901-12	1 VIAL, MULTI-DOSE in 1 CARTON (69918-901-12) / 10 mL in 1 VIAL, MULTI-DOSE
4 ug/mL	69918-901-11	69918-901	69918-0901-11	1 VIAL, MULTI-DOSE in 1 CARTON (69918-901-11) / 10 mL in 1 VIAL, MULTI-DOSE

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

Labeler

Teva Pharmaceuticals

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