NDC 63415-0071OTC monographFDA BULK INGREDIENT

Generic formulation

Active substance: Alendronate Sodium

FDA labeler: Assia Chemical Industries Ltd - Teva Tech Site

30 formulations • 67 package configurations

All 97 registered NDCs — click to copy

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Generic formulation (Alendronate Sodium) NDC 63415-0071 converts to 63415-0071-00 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: 63415-0071

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

63415-0071-00

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
70 mg/75mL	0054-0282-59	0054-0282	00054-0282-59	4 BOTTLE, UNIT-DOSE in 1 CARTON (0054-0282-59) / 75 mL in 1 BOTTLE, UNIT-DOSE
35 mg/1	0115-1679-26	0115-1679	00115-1679-26	12 BLISTER PACK in 1 CARTON (0115-1679-26) / 1 TABLET in 1 BLISTER PACK (0115-1679-30)
Inner component	0115-1679-30	0115-1679	00115-1679-30	Inner component of kit (0115-1679-26)
35 mg/1	0115-1679-34	0115-1679	00115-1679-34	4 BLISTER PACK in 1 CARTON (0115-1679-34) / 1 TABLET in 1 BLISTER PACK (0115-1679-30)
40 mg/1	0115-1680-08	0115-1680	00115-1680-08	30 TABLET in 1 BOTTLE (0115-1680-08)
70 mg/1	0115-1681-26	0115-1681	00115-1681-26	12 BLISTER PACK in 1 CARTON (0115-1681-26) / 1 TABLET in 1 BLISTER PACK (0115-1681-30)
Inner component	0115-1681-30	0115-1681	00115-1681-30	Inner component of kit (0115-1681-26)
70 mg/1	0115-1681-34	0115-1681	00115-1681-34	4 BLISTER PACK in 1 CARTON (0115-1681-34) / 1 TABLET in 1 BLISTER PACK (0115-1681-30)
70 mg/1	71205-048-04	71205-048	71205-0048-04	1 BLISTER PACK in 1 CARTON (71205-048-04) / 4 TABLET in 1 BLISTER PACK
70 mg/1	68788-7130-4	68788-7130	68788-7130-04	4 TABLET in 1 BLISTER PACK (68788-7130-4)
70 mg/1	50090-3126-0	50090-3126	50090-3126-00	1 BLISTER PACK in 1 CARTON (50090-3126-0) / 4 TABLET in 1 BLISTER PACK
70 mg/1	50090-3126-1	50090-3126	50090-3126-01	12 TABLET in 1 BOTTLE, PLASTIC (50090-3126-1)
35 mg/1	70518-1192-1	70518-1192	70518-1192-01	3 BLISTER PACK in 1 CARTON (70518-1192-1) / 4 TABLET in 1 BLISTER PACK
70 mg/1	65862-329-01	65862-329	65862-0329-01	100 TABLET in 1 BOTTLE (65862-329-01)
70 mg/1	65862-329-04	65862-329	65862-0329-04	1 BLISTER PACK in 1 CARTON (65862-329-04) / 4 TABLET in 1 BLISTER PACK
70 mg/1	65862-329-05	65862-329	65862-0329-05	500 TABLET in 1 BOTTLE (65862-329-05)
70 mg/1	65862-329-08	65862-329	65862-0329-08	3 BLISTER PACK in 1 CARTON (65862-329-08) / 4 TABLET in 1 BLISTER PACK
70 mg/1	65862-329-10	65862-329	65862-0329-10	10 BLISTER PACK in 1 CARTON (65862-329-10) / 10 TABLET in 1 BLISTER PACK
70 mg/1	65862-329-20	65862-329	65862-0329-20	5 BLISTER PACK in 1 CARTON (65862-329-20) / 4 TABLET in 1 BLISTER PACK
10 mg/1	65862-327-01	65862-327	65862-0327-01	100 TABLET in 1 BOTTLE (65862-327-01)
10 mg/1	65862-327-10	65862-327	65862-0327-10	10 BLISTER PACK in 1 CARTON (65862-327-10) / 10 TABLET in 1 BLISTER PACK
10 mg/1	65862-327-30	65862-327	65862-0327-30	30 TABLET in 1 BOTTLE (65862-327-30)
10 mg/1	65862-327-99	65862-327	65862-0327-99	1000 TABLET in 1 BOTTLE (65862-327-99)
35 mg/1	65862-328-04	65862-328	65862-0328-04	1 BLISTER PACK in 1 CARTON (65862-328-04) / 4 TABLET in 1 BLISTER PACK
35 mg/1	65862-328-08	65862-328	65862-0328-08	3 BLISTER PACK in 1 CARTON (65862-328-08) / 4 TABLET in 1 BLISTER PACK
35 mg/1	65862-328-10	65862-328	65862-0328-10	10 BLISTER PACK in 1 CARTON (65862-328-10) / 10 TABLET in 1 BLISTER PACK
35 mg/1	65862-328-20	65862-328	65862-0328-20	5 BLISTER PACK in 1 CARTON (65862-328-20) / 4 TABLET in 1 BLISTER PACK
70 mg/1	68071-3340-4	68071-3340	68071-3340-04	4 TABLET in 1 BOX (68071-3340-4)
10 mg/1	16714-631-01	16714-631	16714-0631-01	30 TABLET in 1 BOTTLE (16714-631-01)
10 mg/1	16714-631-02	16714-631	16714-0631-02	100 TABLET in 1 BOTTLE (16714-631-02)
10 mg/1	16714-631-11	16714-631	16714-0631-11	10 BLISTER PACK in 1 CARTON (16714-631-11) / 10 TABLET in 1 BLISTER PACK (16714-631-10)
Inner component	16714-631-10	16714-631	16714-0631-10	Inner component of kit (16714-631-11)
35 mg/1	16714-632-01	16714-632	16714-0632-01	1 BLISTER PACK in 1 CARTON (16714-632-01) / 4 TABLET in 1 BLISTER PACK
35 mg/1	16714-632-02	16714-632	16714-0632-02	5 BLISTER PACK in 1 CARTON (16714-632-02) / 4 TABLET in 1 BLISTER PACK
35 mg/1	16714-632-11	16714-632	16714-0632-11	10 BLISTER PACK in 1 CARTON (16714-632-11) / 10 TABLET in 1 BLISTER PACK (16714-632-10)
Inner component	16714-632-10	16714-632	16714-0632-10	Inner component of kit (16714-632-11)
70 mg/1	16714-633-01	16714-633	16714-0633-01	1 BLISTER PACK in 1 CARTON (16714-633-01) / 4 TABLET in 1 BLISTER PACK
70 mg/1	16714-633-02	16714-633	16714-0633-02	5 BLISTER PACK in 1 CARTON (16714-633-02) / 4 TABLET in 1 BLISTER PACK
70 mg/1	16714-633-11	16714-633	16714-0633-11	10 BLISTER PACK in 1 CARTON (16714-633-11) / 10 TABLET in 1 BLISTER PACK (16714-633-10)
Inner component	16714-633-10	16714-633	16714-0633-10	Inner component of kit (16714-633-11)
70 mg/1	76282-682-46	76282-682	76282-0682-46	3 BLISTER PACK in 1 CARTON (76282-682-46) / 4 TABLET in 1 BLISTER PACK (76282-682-45)
Inner component	76282-682-45	76282-682	76282-0682-45	Inner component of kit (76282-682-46)
35 mg/1	76282-681-46	76282-681	76282-0681-46	3 BLISTER PACK in 1 CARTON (76282-681-46) / 4 TABLET in 1 BLISTER PACK (76282-681-45)
Inner component	76282-681-45	76282-681	76282-0681-45	Inner component of kit (76282-681-46)
35 mg/1	50090-5474-0	50090-5474	50090-5474-00	1 BLISTER PACK in 1 CARTON (50090-5474-0) / 4 TABLET in 1 BLISTER PACK
70 mg/1	50090-4692-0	50090-4692	50090-4692-00	1 BLISTER PACK in 1 CARTON (50090-4692-0) / 4 TABLET in 1 BLISTER PACK
70 mg/1	50090-4692-1	50090-4692	50090-4692-01	3 BLISTER PACK in 1 CARTON (50090-4692-1) / 4 TABLET in 1 BLISTER PACK
70 mg/75mL	70954-264-10	70954-264	70954-0264-10	4 BOTTLE in 1 CARTON (70954-264-10) / 75 mL in 1 BOTTLE
70 mg/1	70518-0033-0	70518-0033	70518-0033-00	12 TABLET in 1 BLISTER PACK (70518-0033-0)
70 mg/1	68071-3771-5	68071-3771	68071-3771-05	15 BLISTER PACK in 1 CARTON (68071-3771-5) / 1 TABLET in 1 BLISTER PACK
10 mg/1	64980-340-01	64980-340	64980-0340-01	100 TABLET in 1 BOTTLE (64980-340-01)
10 mg/1	64980-340-03	64980-340	64980-0340-03	30 TABLET in 1 BOTTLE (64980-340-03)
35 mg/1	64980-341-12	64980-341	64980-0341-12	3 BLISTER PACK in 1 CARTON (64980-341-12) / 4 TABLET in 1 BLISTER PACK
35 mg/1	64980-341-14	64980-341	64980-0341-14	1 BLISTER PACK in 1 CARTON (64980-341-14) / 4 TABLET in 1 BLISTER PACK
70 mg/1	64980-342-01	64980-342	64980-0342-01	100 TABLET in 1 BOTTLE (64980-342-01)
70 mg/1	64980-342-14	64980-342	64980-0342-14	1 BLISTER PACK in 1 CARTON (64980-342-14) / 4 TABLET in 1 BLISTER PACK
70 mg/1	64980-342-50	64980-342	64980-0342-50	500 TABLET in 1 BOTTLE (64980-342-50)
35 mg/1	69097-223-16	69097-223	69097-0223-16	1 BLISTER PACK in 1 CARTON (69097-223-16) / 4 TABLET in 1 BLISTER PACK
35 mg/1	69097-223-76	69097-223	69097-0223-76	3 BLISTER PACK in 1 CARTON (69097-223-76) / 4 TABLET in 1 BLISTER PACK
70 mg/1	69097-224-16	69097-224	69097-0224-16	1 BLISTER PACK in 1 CARTON (69097-224-16) / 4 TABLET in 1 BLISTER PACK
70 mg/1	69097-224-76	69097-224	69097-0224-76	3 BLISTER PACK in 1 CARTON (69097-224-76) / 4 TABLET in 1 BLISTER PACK
70 mg/1	50090-5677-0	50090-5677	50090-5677-00	1 BLISTER PACK in 1 CARTON (50090-5677-0) / 4 TABLET in 1 BLISTER PACK
70 mg/1	50090-5677-1	50090-5677	50090-5677-01	3 BLISTER PACK in 1 CARTON (50090-5677-1) / 4 TABLET in 1 BLISTER PACK
5 mg/1	0115-1676-01	0115-1676	00115-1676-01	100 TABLET in 1 BOTTLE (0115-1676-01)
5 mg/1	0115-1676-08	0115-1676	00115-1676-08	30 TABLET in 1 BOTTLE (0115-1676-08)
10 mg/1	0115-1678-01	0115-1678	00115-1678-01	100 TABLET in 1 BOTTLE (0115-1678-01)
10 mg/1	0115-1678-08	0115-1678	00115-1678-08	30 TABLET in 1 BOTTLE (0115-1678-08)

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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