cetrorelix acetate

Generic: cetrorelix acetate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetrorelix acetate
Generic Name cetrorelix acetate
Labeler gland pharma limited
Dosage Form KIT
Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-600
Product ID 68083-600_ab90e510-eecd-4d5f-b2df-059d3cbfc8f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218150
Listing Expiration 2026-12-31
Marketing Start 2024-04-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083600
Hyphenated Format 68083-600

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 ANDA218150 (source: ndc)

Resolved Composition

Strengths
  • 0.25 mg
  • 0.27 mg
  • 1 ml
source: label
Packaging
  • 1 TRAY in 1 CARTON (68083-600-01) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (68083-598-01) * 1 mL in 1 SYRINGE (68083-599-01)
source: ndc

Packages (1)

68083-600-01 1 TRAY in 1 CARTON (68083-600-01) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (68083-598-01) * 1 mL in 1 SYRINGE (68083-599-01)

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 
{"spl_id": "ab90e510-eecd-4d5f-b2df-059d3cbfc8f0", "openfda": {"rxcui": ["283402"], "spl_set_id": ["89f8f8ee-68ac-4ed0-a7e3-ffd6e0c1290a"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 CARTON (68083-600-01)  / 1 KIT in 1 TRAY *  1 mL in 1 VIAL, SINGLE-DOSE (68083-598-01)  *  1 mL in 1 SYRINGE (68083-599-01)", "package_ndc": "68083-600-01", "marketing_start_date": "20240425"}], "brand_name": "cetrorelix acetate", "product_id": "68083-600_ab90e510-eecd-4d5f-b2df-059d3cbfc8f0", "dosage_form": "KIT", "product_ndc": "68083-600", "generic_name": "cetrorelix acetate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "cetrorelix acetate", "application_number": "ANDA218150", "marketing_category": "ANDA", "marketing_start_date": "20240425", "listing_expiration_date": "20261231"}