NDC 17088-0100Prescription (Rx only)FDA DRUG FOR FURTHER PROCESSING

Generic formulation

Active substance: Letrozole

23 formulations • 47 package configurations

All 70 registered NDCs — click to copy

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Generic formulation (Letrozole) NDC 17088-0100 converts to 17088-0100-01 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: 17088-0100

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

17088-0100-01

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
2.5 mg/1	69117-0004-1	69117-0004	69117-0004-01	30 TABLET, FILM COATED in 1 BOTTLE (69117-0004-1)Sample
2.5 mg/1	71335-2396-1	71335-2396	71335-2396-01	30 TABLET, FILM COATED in 1 BOTTLE (71335-2396-1)
2.5 mg/1	71335-2396-2	71335-2396	71335-2396-02	10 TABLET, FILM COATED in 1 BOTTLE (71335-2396-2)
2.5 mg/1	71335-2396-3	71335-2396	71335-2396-03	90 TABLET, FILM COATED in 1 BOTTLE (71335-2396-3)
2.5 mg/1	71335-2396-4	71335-2396	71335-2396-04	40 TABLET, FILM COATED in 1 BOTTLE (71335-2396-4)
2.5 mg/1	62135-491-30	62135-491	62135-0491-30	30 TABLET, FILM COATED in 1 BOTTLE (62135-491-30)
2.5 mg/1	62135-491-90	62135-491	62135-0491-90	90 TABLET, FILM COATED in 1 BOTTLE (62135-491-90)
2.5 mg/1	23155-875-03	23155-875	23155-0875-03	30 TABLET, FILM COATED in 1 BOTTLE (23155-875-03)Sample
2.5 mg/1	23155-875-09	23155-875	23155-0875-09	90 TABLET, FILM COATED in 1 BOTTLE (23155-875-09)Sample
2.5 mg/1	23155-875-10	23155-875	23155-0875-10	1000 TABLET, FILM COATED in 1 BOTTLE (23155-875-10)Sample
2.5 mg/1	63850-0025-1	63850-0025	63850-0025-01	30 TABLET in 1 BOTTLE (63850-0025-1)
2.5 mg/1	63850-0025-4	63850-0025	63850-0025-04	1000 TABLET in 1 BOTTLE (63850-0025-4)
2.5 mg/1	51991-759-10	51991-759	51991-0759-10	1000 TABLET in 1 BOTTLE (51991-759-10)
2.5 mg/1	51991-759-33	51991-759	51991-0759-33	30 TABLET in 1 BOTTLE (51991-759-33)
2.5 mg/1	51991-759-90	51991-759	51991-0759-90	90 TABLET in 1 BOTTLE (51991-759-90)
2.5 mg/1	50268-476-15	50268-476	50268-0476-15	50 BLISTER PACK in 1 BOX (50268-476-15) / 1 TABLET in 1 BLISTER PACK (50268-476-11)
Inner component	50268-476-11	50268-476	50268-0476-11	Inner component of kit (50268-476-15)
2.5 mg/1	68071-2167-4	68071-2167	68071-2167-04	40 TABLET, FILM COATED in 1 BOTTLE (68071-2167-4)
2.5 mg/1	16729-034-10	16729-034	16729-0034-10	30 TABLET, FILM COATED in 1 BOTTLE (16729-034-10)
2.5 mg/1	16729-034-15	16729-034	16729-0034-15	90 TABLET, FILM COATED in 1 BOTTLE (16729-034-15)
2.5 mg/1	17856-0032-1	17856-0032	17856-0032-01	100 POUCH in 1 BOX, UNIT-DOSE (17856-0032-1) / 1 TABLET, FILM COATED in 1 POUCH
2.5 mg/1	51407-986-90	51407-986	51407-0986-90	90 TABLET, FILM COATED in 1 BOTTLE (51407-986-90)
2.5 mg/1	71335-1526-1	71335-1526	71335-1526-01	30 TABLET in 1 BOTTLE (71335-1526-1)
2.5 mg/1	71335-1526-2	71335-1526	71335-1526-02	10 TABLET in 1 BOTTLE (71335-1526-2)
2.5 mg/1	71335-1526-3	71335-1526	71335-1526-03	90 TABLET in 1 BOTTLE (71335-1526-3)
2.5 mg/1	71335-1526-4	71335-1526	71335-1526-04	40 TABLET in 1 BOTTLE (71335-1526-4)
2.5 mg/1	68071-5264-3	68071-5264	68071-5264-03	30 TABLET, FILM COATED in 1 BOTTLE (68071-5264-3)
2.5 mg/1	80005-139-08	80005-139	80005-0139-08	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80005-139-08)
2.5 mg/1	80005-139-10	80005-139	80005-0139-10	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80005-139-10)
2.5 mg/1	0093-7620-56	0093-7620	00093-7620-56	30 TABLET, FILM COATED in 1 BOTTLE (0093-7620-56)
2.5 mg/1	50090-8002-0	50090-8002	50090-8002-00	90 TABLET in 1 BOTTLE (50090-8002-0)
2.5 mg/1	59651-180-30	59651-180	59651-0180-30	30 TABLET, FILM COATED in 1 BOTTLE (59651-180-30)
2.5 mg/1	59651-180-90	59651-180	59651-0180-90	90 TABLET, FILM COATED in 1 BOTTLE (59651-180-90)
2.5 mg/1	50090-3474-0	50090-3474	50090-3474-00	90 TABLET, FILM COATED in 1 BOTTLE (50090-3474-0)
2.5 mg/1	63629-7819-1	63629-7819	63629-7819-01	30 TABLET, FILM COATED in 1 BOTTLE (63629-7819-1)
2.5 mg/1	63629-7819-2	63629-7819	63629-7819-02	10 TABLET, FILM COATED in 1 BOTTLE (63629-7819-2)
2.5 mg/1	63629-7819-3	63629-7819	63629-7819-03	90 TABLET, FILM COATED in 1 BOTTLE (63629-7819-3)
2.5 mg/1	63629-7819-4	63629-7819	63629-7819-04	40 TABLET, FILM COATED in 1 BOTTLE (63629-7819-4)
2.5 mg/1	42291-374-30	42291-374	42291-0374-30	30 TABLET, FILM COATED in 1 BOTTLE (42291-374-30)
2.5 mg/1	42291-374-90	42291-374	42291-0374-90	90 TABLET, FILM COATED in 1 BOTTLE (42291-374-90)
2.5 mg/1	71205-587-30	71205-587	71205-0587-30	30 TABLET, FILM COATED in 1 BOTTLE (71205-587-30)
2.5 mg/1	71205-587-60	71205-587	71205-0587-60	60 TABLET, FILM COATED in 1 BOTTLE (71205-587-60)
2.5 mg/1	71205-587-90	71205-587	71205-0587-90	90 TABLET, FILM COATED in 1 BOTTLE (71205-587-90)
2.5 mg/1	24979-726-07	24979-726	24979-0726-07	90 TABLET, FILM COATED in 1 BOTTLE (24979-726-07)
2.5 mg/1	55111-646-30	55111-646	55111-0646-30	30 TABLET, FILM COATED in 1 BOTTLE (55111-646-30)
2.5 mg/1	55111-646-78	55111-646	55111-0646-78	10 BLISTER PACK in 1 CARTON (55111-646-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-646-79)
Inner component	55111-646-79	55111-646	55111-0646-79	Inner component of kit (55111-646-78)

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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