cetrorelix acetate

Generic: cetrorelix acetate

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

Drug Facts

Product Profile

Brand Name cetrorelix acetate
Generic Name cetrorelix acetate
Labeler meitheal pharmaceuticals inc.
Dosage Form KIT
Routes
SUBCUTANEOUS
Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-558
Product ID 71288-558_1f143808-6446-45a1-9a8c-9e58a26c22cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214540
Listing Expiration 2026-12-31
Marketing Start 2024-04-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288558
Hyphenated Format 71288-558

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 acetate (source: ndc)
Generic Name cetrorelix acetate (source: ndc)
Application Number ANDA214540 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 0.25 mg
  • 0.27 mg
  • 1 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (71288-558-90) * 2 mL in 1 VIAL, SINGLE-DOSE (71288-556-02) * 1 mL in 1 SYRINGE, GLASS (71288-557-81)
source: ndc

Packages (1)

71288-558-90 1 KIT in 1 CARTON (71288-558-90) * 2 mL in 1 VIAL, SINGLE-DOSE (71288-556-02) * 1 mL in 1 SYRINGE, GLASS (71288-557-81)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Cetrorelix Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "1f143808-6446-45a1-9a8c-9e58a26c22cb", "openfda": {"rxcui": ["283402"], "spl_set_id": ["9b3057ac-6cac-4509-a355-df76247b992c"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (71288-558-90)  *  2 mL in 1 VIAL, SINGLE-DOSE (71288-556-02)  *  1 mL in 1 SYRINGE, GLASS (71288-557-81)", "package_ndc": "71288-558-90", "marketing_start_date": "20240424"}], "brand_name": "Cetrorelix Acetate", "product_id": "71288-558_1f143808-6446-45a1-9a8c-9e58a26c22cb", "dosage_form": "KIT", "product_ndc": "71288-558", "generic_name": "Cetrorelix Acetate", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cetrorelix Acetate", "application_number": "ANDA214540", "marketing_category": "ANDA", "marketing_start_date": "20240424", "listing_expiration_date": "20261231"}