cetrorelix acetate

Generic: cetrorelix acetate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetrorelix acetate
Generic Name cetrorelix acetate
Labeler fresenius kabi usa, llc
Dosage Form KIT
Manufacturer
FRESENIUS KABI USA, LLC

Identifiers & Regulatory

Product NDC 65219-292
Product ID 65219-292_96fa0188-c4cd-4e23-b376-457bd6df8e2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218150
Listing Expiration 2026-12-31
Marketing Start 2024-07-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219292
Hyphenated Format 65219-292

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
  • 0.27 mg
  • 0.25 mg
  • 1 ml
source: label
Packaging
  • 1 TRAY in 1 CARTON (65219-292-77) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (65219-290-02) * 1 mL in 1 SYRINGE (65219-286-01)
source: ndc

Packages (1)

65219-292-77 1 TRAY in 1 CARTON (65219-292-77) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (65219-290-02) * 1 mL in 1 SYRINGE (65219-286-01)

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": "96fa0188-c4cd-4e23-b376-457bd6df8e2f", "openfda": {"rxcui": ["283402"], "spl_set_id": ["c9c50fcb-b28d-4085-9116-b38a21d31b99"], "manufacturer_name": ["FRESENIUS KABI USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 CARTON (65219-292-77)  / 1 KIT in 1 TRAY *  1 mL in 1 VIAL, SINGLE-DOSE (65219-290-02)  *  1 mL in 1 SYRINGE (65219-286-01)", "package_ndc": "65219-292-77", "marketing_start_date": "20240731"}], "brand_name": "cetrorelix acetate", "product_id": "65219-292_96fa0188-c4cd-4e23-b376-457bd6df8e2f", "dosage_form": "KIT", "product_ndc": "65219-292", "generic_name": "cetrorelix acetate", "labeler_name": "FRESENIUS KABI USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "cetrorelix acetate", "application_number": "ANDA218150", "marketing_category": "ANDA", "marketing_start_date": "20240731", "listing_expiration_date": "20261231"}