Home NDC 71288-558 Cetrorelix Acetate
Product NDC 71288-558
11-digit product format 712880558
Labeler code 71288
Product ID 71288-558_1f143808-6446-45a1-9a8c-9e58a26c22cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cetrorelix Acetate
Dosage form KIT
Route SUBCUTANEOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA214540
Marketing category ANDA
Marketing start 2024-04-24
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214540-001 CETRORELIX ACETATE CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214540-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Cetrorelix Acetate
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283402 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71288-558-90 Cetrorelix Acetate 1 in 1 CARTON KIT 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-558 CETRORELIX ACETATE KIT [MEITHEAL PHARMACEUTICALS INC.] 7 Current NDC, 1 package rows 20241212_9b3057ac-6cac-4509-a355-df76247b992c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71288-558-90 71288055890 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) 1 kit 2024-04-24 No No Current