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
Marketing end 2027-04-30
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 43 .
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 2026-09-14 22:38:34 2026-08 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214540-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-24 caaa826d4ba7…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Cetrorelix Acetate 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end 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 2027-04-30 No No Historical