Home NDC 68083-600-01 cetrorelix acetate
Product NDC 68083-600
Requested package NDC 68083-600-01
11-digit product format 680830600
Labeler code 68083
Product ID 68083-600_ab90e510-eecd-4d5f-b2df-059d3cbfc8f0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cetrorelix acetate
Dosage form KIT
Labeler Gland Pharma Limited
Application ANDA218150
Marketing category ANDA
Marketing start 2024-04-25
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 A218150-001 CETRORELIX ACETATE CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218150-001 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 A218150-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218150-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218150-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218150-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218150-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218150-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218150-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218150-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218150-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218150-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218150-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218150-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218150-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218150-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218150-001 CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP 2024-04-25 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 68083-600-01 cetrorelix acetate 1 in 1 CARTON KIT 1 6 68083-600-01 cetrorelix acetate 1 in 1 TRAY KIT 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-600 CETRORELIX ACETATE KIT [GLAND PHARMA LIMITED] 6 Current NDC, 2 package rows 20240809_89f8f8ee-68ac-4ed0-a7e3-ffd6e0c1290a.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 · 2 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 68083-600-01 68083060001 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) 1 tray 2024-04-25 No No Current