Home NDC 44087-1225 Cetrotide
Product NDC 44087-1225
11-digit product format 440871225
Labeler code 44087
Product ID 44087-1225_716029d9-4462-4732-846c-456e74363b83
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cetrorelix acetate
Dosage form KIT
Route SUBCUTANEOUS
Labeler EMD Serono, Inc.
Application NDA021197
Marketing category NDA
Marketing start 2000-08-11
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021197-001 CETROTIDE CETRORELIX ACETATE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 N021197-002 CETROTIDE CETRORELIX ACETATE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021197-001 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.
Product history page 1 of 3 · 82 observed 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 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021197-001 CETROTIDE EQ 0.25MG BASE/VIAL POWDER / SUBCUTANEOUS AP RLD, RS 2000-08-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021197-002 CETROTIDE EQ 3MG BASE/VIAL POWDER / SUBCUTANEOUS RLD 2000-08-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021197-001 CETROTIDE EQ 0.25MG BASE/ML INJECTABLE / INJECTION RLD, RS 2000-08-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021197-002 CETROTIDE EQ 3MG BASE/ML INJECTABLE / INJECTION 2000-08-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021197-001 CETROTIDE EQ 0.25MG BASE/ML INJECTABLE / INJECTION RLD, RS 2000-08-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021197-002 CETROTIDE EQ 3MG BASE/ML INJECTABLE / INJECTION 2000-08-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021197-001 CETROTIDE EQ 0.25MG BASE/ML INJECTABLE / INJECTION RLD, RS 2000-08-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021197-002 CETROTIDE EQ 3MG BASE/ML INJECTABLE / INJECTION 2000-08-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021197-001 CETROTIDE EQ 0.25MG BASE/ML INJECTABLE / INJECTION RLD, RS 2000-08-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021197-002 CETROTIDE EQ 3MG BASE/ML INJECTABLE / INJECTION 2000-08-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021197-001 CETROTIDE EQ 0.25MG BASE/ML INJECTABLE / INJECTION RLD, RS 2000-08-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021197-002 CETROTIDE EQ 3MG BASE/ML INJECTABLE / INJECTION 2000-08-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021197-001 CETROTIDE EQ 0.25MG BASE/ML INJECTABLE / INJECTION RLD, RS 2000-08-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021197-002 CETROTIDE EQ 3MG BASE/ML INJECTABLE / INJECTION 2000-08-11 782e0a99824c…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021197-001 6319192 2019-04-23 U-426 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021197-002 6319192 2019-04-23 U-426 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021197-001 6319192 2019-04-23 U-426 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021197-002 6319192 2019-04-23 U-426 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021197-001 6319192 2019-04-23 U-426 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021197-002 6319192 2019-04-23 U-426 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021197-001 6319192 2019-04-23 U-426 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021197-002 6319192 2019-04-23 U-426 ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Cetrotide
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283402 Internal RxNorm lookup 284441 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44087-1225-1 Cetrotide 1 in 1 CARTON KIT 1 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44087-1225 CETROTIDE (CETRORELIX ACETATE) KIT [EMD SERONO, INC.] 17 Current NDC, Legacy NDC, 1 package rows 20240619_aca7768e-28a7-4027-b1d8-e66247665f79.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 Marketing end Sample Exclude flag Status 44087-1225-1 44087122501 1 KIT in 1 CARTON (44087-1225-1) * 1 mL in 1 VIAL, GLASS * 1 mL in 1 SYRINGE, GLASS 1 kit 2000-08-11 0000-00-00 No No Current