Cetrorelix

Product NDC: 0480-5795
11-digit product format: 004805795
Labeler code: 0480
Product ID: 0480-5795_f8c62e7c-4615-463b-af59-b820a9e3b911
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cetrorelix Acetate
Dosage form: KIT
Route: SUBCUTANEOUS
Labeler: Teva Pharmaceuticals, Inc.
Application: ANDA215737
Marketing category: ANDA
Marketing start: 2023-12-14
Marketing end: 2026-06-30
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0480-5795		D	Discontinued by firm		2026-08-10
excluded package	package	0480-5795	0480-5795-08	D	Discontinued by firm		2026-08-10

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
A215737-001	CETRORELIX ACETATE	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP		2022-08-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A215737-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215737-001	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER / SUBCUTANEOUS	AP	2022-08-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215737-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215737-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215737-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215737-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215737-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215737-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215737-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215737-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215737-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215737-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215737-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215737-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215737-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215737-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215737-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215737-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215737-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215737-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215737-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215737-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215737-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215737-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215737-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215737-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215737-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215737-001	AP	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215737-001	AP	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A215737-001	CGT	2023-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215737-001	CGT	2023-04-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215737-001	CGT	2023-04-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215737-001	CGT	2023-04-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215737-001	CGT	2023-04-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215737-001	CGT	2023-04-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215737-001	CGT	2023-04-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215737-001	CGT	2023-04-22	`3a93d1ddd44b…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
52b64100-83c4-4b2c-91ed-8d03f311b48c	Product name	4	20260317

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0480-5795-08	2025-07-29	C162847	48780-1	3b156c62-3403-fb37-e063-e6dba90a4e07	Cetrorelix Acetate for Injection 0.25 mg FOR SUBCUTANEOUS USE ONLY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0480-5795-08	Cetrorelix	1 in 1 CARTON	KIT	1		6
0480-5795-08	Cetrorelix	1 in 1 TRAY	KIT	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0480-5795-08	EA - Each	0480-5795	2dbe90cc-61eb-4976-815c-6cac0d0c2207	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0480-5795	CETRORELIX (CETRORELIX ACETATE) KIT [TEVA PHARMACEUTICALS, INC.]	3	Current NDC, 2 package rows	20240725_f91c971b-89d7-4306-966d-8ecc1afc16d1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W9Y8L7GP4C	CETRORELIX ACETATE	130143-01-0	Cetrorelix Acetate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283402	cetrorelix 0.25 MG Injection	PSN	f91c971b-89d7-4306-966d-8ecc1afc16d1	6
283402	cetrorelix 0.25 MG Injection	SCD	f91c971b-89d7-4306-966d-8ecc1afc16d1	6
283402	cetrorelix (as cetrorelix acetate) 0.25 MG Injection	SY	f91c971b-89d7-4306-966d-8ecc1afc16d1	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0480-5795-08	00480579508	1 TRAY in 1 CARTON (0480-5795-08) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (0480-3583-01) * 1 mL in 1 SYRINGE (0480-3584-21)	1 tray	2023-12-14	2026-06-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetrorelix Acetate for Injection 0.25 mg FOR SUBCUTANEOUS USE ONLY	Teva Pharmaceuticals, Inc.	2024-06-30	HUMAN PRESCRIPTION DRUG LABEL	6