cetrorelix

Generic: cetrorelix acetate

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetrorelix
Generic Name cetrorelix acetate
Labeler teva pharmaceuticals, inc.
Dosage Form KIT
Routes
SUBCUTANEOUS
Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-5795
Product ID 0480-5795_f8c62e7c-4615-463b-af59-b820a9e3b911
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215737
Marketing Start 2023-12-14
Marketing End 2026-06-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04805795
Hyphenated Format 0480-5795

Supplemental Identifiers

RxCUI
283402

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cetrorelix (source: ndc)
Generic Name cetrorelix acetate (source: ndc)
Application Number ANDA215737 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 0.25 mg
  • 0.27 mg
  • 1 ml
source: label
Packaging
  • 1 TRAY in 1 CARTON (0480-5795-08) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (0480-3583-01) * 1 mL in 1 SYRINGE (0480-3584-21)
source: ndc

Packages (1)

0480-5795-08 1 TRAY in 1 CARTON (0480-5795-08) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (0480-3583-01) * 1 mL in 1 SYRINGE (0480-3584-21)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Cetrorelix ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "f8c62e7c-4615-463b-af59-b820a9e3b911", "openfda": {"rxcui": ["283402"], "spl_set_id": ["f91c971b-89d7-4306-966d-8ecc1afc16d1"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 CARTON (0480-5795-08)  / 1 KIT in 1 TRAY *  1 mL in 1 VIAL, SINGLE-DOSE (0480-3583-01)  *  1 mL in 1 SYRINGE (0480-3584-21)", "package_ndc": "0480-5795-08", "marketing_end_date": "20260630", "marketing_start_date": "20231214"}], "brand_name": "Cetrorelix", "product_id": "0480-5795_f8c62e7c-4615-463b-af59-b820a9e3b911", "dosage_form": "KIT", "product_ndc": "0480-5795", "generic_name": "Cetrorelix Acetate", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cetrorelix", "application_number": "ANDA215737", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20231214"}