NDC 63415-0065OTC monographFDA BULK INGREDIENT

Generic formulation

Active substance: Octreotide Acetate

FDA labeler: Assia Chemical Industries Ltd - Teva Tech Site

29 formulations • 54 package configurations

All 83 registered NDCs — click to copy

In one line

Generic formulation (Octreotide Acetate) NDC 63415-0065 converts to 63415-0065-00 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: 63415-0065

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

63415-0065-00

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
100 ug/mL	0641-6175-10	0641-6175	00641-6175-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6175-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6175-01)
Vial component	0641-6175-01	0641-6175	00641-6175-01	Inner component of kit (0641-6175-10)
50 ug/mL	71288-566-02	71288-566	71288-0566-02	10 VIAL, SINGLE-DOSE in 1 CARTON (71288-566-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-566-01)
Vial component	71288-566-01	71288-566	71288-0566-01	Inner component of kit (71288-566-02)
100 ug/mL	71288-567-02	71288-567	71288-0567-02	10 VIAL, SINGLE-DOSE in 1 CARTON (71288-567-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-567-01)
Vial component	71288-567-01	71288-567	71288-0567-01	Inner component of kit (71288-567-02)
500 ug/mL	71288-568-02	71288-568	71288-0568-02	10 VIAL, SINGLE-DOSE in 1 CARTON (71288-568-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-568-01)
Vial component	71288-568-01	71288-568	71288-0568-01	Inner component of kit (71288-568-02)
500 ug/mL	0641-6176-10	0641-6176	00641-6176-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6176-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6176-01)
Vial component	0641-6176-01	0641-6176	00641-6176-01	Inner component of kit (0641-6176-10)
200 ug/mL	0641-6177-01	0641-6177	00641-6177-01	1 VIAL, MULTI-DOSE in 1 CARTON (0641-6177-01) / 5 mL in 1 VIAL, MULTI-DOSE
1000 ug/mL	0641-6178-01	0641-6178	00641-6178-01	1 VIAL, MULTI-DOSE in 1 CARTON (0641-6178-01) / 5 mL in 1 VIAL, MULTI-DOSE
100 ug/mL	52958-046-10	52958-046	52958-0046-10	10 VIAL, GLASS in 1 CARTON (52958-046-10) / 1 mL in 1 VIAL, GLASS (52958-046-01)
Vial component	52958-046-01	52958-046	52958-0046-01	Inner component of kit (52958-046-10)
500 ug/mL	67457-246-01	67457-246	67457-0246-01	10 SYRINGE in 1 CARTON (67457-246-01) / 1 mL in 1 SYRINGE (67457-246-00)
Prefilled syringe	67457-246-00	67457-246	67457-0246-00	Inner component of kit (67457-246-01)
50 ug/mL	67457-239-01	67457-239	67457-0239-01	10 SYRINGE in 1 CARTON (67457-239-01) / 1 mL in 1 SYRINGE (67457-239-00)
Prefilled syringe	67457-239-00	67457-239	67457-0239-00	Inner component of kit (67457-239-01)
100 ug/mL	67457-245-01	67457-245	67457-0245-01	10 SYRINGE in 1 CARTON (67457-245-01) / 1 mL in 1 SYRINGE (67457-245-00)
Prefilled syringe	67457-245-00	67457-245	67457-0245-00	Inner component of kit (67457-245-01)
Outer kit carton	67457-759-20	67457-759	67457-0759-20	1 KIT in 1 KIT (67457-759-20) * 6 mL in 1 VIAL (67457-757-20) * 2 mL in 1 SYRINGE (67457-758-02)
Vial component	67457-757-20	67457-759	67457-0757-20	Inner component of kit (67457-759-20)
Vial component	67457-758-02	67457-759	67457-0758-02	Inner component of kit (67457-759-20)
Outer kit carton	67457-756-10	67457-756	67457-0756-10	1 KIT in 1 KIT (67457-756-10) * 6 mL in 1 VIAL (67457-754-10) * 2 mL in 1 SYRINGE (67457-755-02)
Vial component	67457-754-10	67457-756	67457-0754-10	Inner component of kit (67457-756-10)
Vial component	67457-755-02	67457-756	67457-0755-02	Inner component of kit (67457-756-10)
Outer kit carton	67457-762-30	67457-762	67457-0762-30	1 KIT in 1 KIT (67457-762-30) * 6 mL in 1 VIAL (67457-760-30) * 2 mL in 1 SYRINGE (67457-761-02)
Vial component	67457-760-30	67457-762	67457-0760-30	Inner component of kit (67457-762-30)
Vial component	67457-761-02	67457-762	67457-0761-02	Inner component of kit (67457-762-30)
200 ug/mL	68083-515-01	68083-515	68083-0515-01	1 VIAL in 1 CARTON (68083-515-01) / 5 mL in 1 VIAL
1000 ug/mL	68083-516-01	68083-516	68083-0516-01	1 VIAL in 1 CARTON (68083-516-01) / 5 mL in 1 VIAL
100 ug/mL	68083-517-10	68083-517	68083-0517-10	10 VIAL in 1 CARTON (68083-517-10) / 1 mL in 1 VIAL
Outer kit carton	0480-9257-08	0480-9257	00480-9257-08	1 KIT in 1 KIT (0480-9257-08) * 8 mL in 1 VIAL, SINGLE-DOSE (0480-9256-01) * 2 mL in 1 SYRINGE (0480-9263-21)
Vial component	0480-9256-01	0480-9257	00480-9256-01	Inner component of kit (0480-9257-08)
Vial component	0480-9263-21	0480-9257	00480-9263-21	Inner component of kit (0480-9257-08)
500 ug/mL	68083-560-10	68083-560	68083-0560-10	10 VIAL in 1 CARTON (68083-560-10) / 1 mL in 1 VIAL
Outer kit carton	0480-9259-08	0480-9259	00480-9259-08	1 KIT in 1 KIT (0480-9259-08) * 8 mL in 1 VIAL, SINGLE-DOSE (0480-9258-01) * 2 mL in 1 SYRINGE (0480-9263-21)
Vial component	0480-9258-01	0480-9259	00480-9258-01	Inner component of kit (0480-9259-08)
100 ug/mL	23155-688-41	23155-688	23155-0688-41	10 VIAL, GLASS in 1 CARTON (23155-688-41) / 1 mL in 1 VIAL, GLASS (23155-688-31)
Vial component	23155-688-31	23155-688	23155-0688-31	Inner component of kit (23155-688-41)
200 ug/mL	23155-685-31	23155-685	23155-0685-31	5 mL in 1 VIAL, GLASS (23155-685-31)
1000 ug/mL	23155-686-31	23155-686	23155-0686-31	5 mL in 1 VIAL, GLASS (23155-686-31)
100 ug/mL	68462-896-10	68462-896	68462-0896-10	10 VIAL in 1 CARTON (68462-896-10) / 1 mL in 1 VIAL (68462-896-01)
Vial component	68462-896-01	68462-896	68462-0896-01	Inner component of kit (68462-896-10)
50 ug/mL	23155-687-41	23155-687	23155-0687-41	10 VIAL, GLASS in 1 CARTON (23155-687-41) / 1 mL in 1 VIAL, GLASS (23155-687-31)
Vial component	23155-687-31	23155-687	23155-0687-31	Inner component of kit (23155-687-41)
500 ug/mL	68462-897-10	68462-897	68462-0897-10	10 VIAL in 1 CARTON (68462-897-10) / 1 mL in 1 VIAL (68462-897-01)
Vial component	68462-897-01	68462-897	68462-0897-01	Inner component of kit (68462-897-10)
Outer kit carton	0480-9262-08	0480-9262	00480-9262-08	1 KIT in 1 KIT (0480-9262-08) * 8 mL in 1 VIAL, SINGLE-DOSE (0480-9260-01) * 2 mL in 1 SYRINGE (0480-9263-21)
Vial component	0480-9260-01	0480-9262	00480-9260-01	Inner component of kit (0480-9262-08)
500 ug/mL	23155-689-41	23155-689	23155-0689-41	10 VIAL, GLASS in 1 CARTON (23155-689-41) / 1 mL in 1 VIAL, GLASS (23155-689-31)
Vial component	23155-689-31	23155-689	23155-0689-31	Inner component of kit (23155-689-41)
50 ug/mL	0641-6174-10	0641-6174	00641-6174-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6174-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6174-01)
Vial component	0641-6174-01	0641-6174	00641-6174-01	Inner component of kit (0641-6174-10)

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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Teva Pharmaceuticals

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Highlights

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