Ganirelix Acetate

Product NDC: 0052-0301
11-digit product format: 000520301
Labeler code: 0052
Product ID: 0052-0301_21680ef9-07e9-4350-8f1b-51232fc3f0e1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ganirelix Acetate
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Organon USA Inc.
Application: NDA021057
Marketing category: NDA
Marketing start: 1999-07-29
Marketing end: 0000-00-00
Substance: GANIRELIX ACETATE
Active strength: 250 ug/.5mL
Pharmacologic classes: Decreased GnRH Secretion [PE],Gonadotropin Releasing Hormone Antagonist [EPC],Gonadotropin Releasing Hormone Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0052-0301		D	Discontinued by firm	2026-08-17
excluded package	package	0052-0301	0052-0301-51	D	Discontinued by firm	2026-08-17
excluded package	package	0052-0301	0052-0301-81	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0052-0301-51	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0052-0301-81	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0052-0301-51	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0052-0301-81	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0052-0301-51	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0052-0301-81	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0052-0301-51	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0052-0301-81	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0052-0301-51	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0052-0301-81	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0052-0301-51	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0052-0301-81	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0052-0301-51	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0052-0301-81	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0052-0301-51	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0052-0301-81	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0052-0301-51	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0052-0301-81	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0052-0301-51	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0052-0301-81	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0052-0301-51	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0052-0301-81	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0052-0301-51	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0052-0301-81	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021057-001	GANIRELIX ACETATE	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021057-001	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 2 · 42 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
2026-08-18 06:07:40	2026-07	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021057-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-07-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021057-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021057-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021057-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021057-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021057-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021057-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021057-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021057-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021057-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021057-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021057-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021057-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021057-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021057-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021057-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021057-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021057-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021057-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021057-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021057-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021057-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021057-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021057-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021057-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021057-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021057-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021057-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021057-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021057-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021057-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021057-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021057-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021057-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021057-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021057-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021057-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021057-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021057-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021057-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021057-001	AP	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0052-0301-51	ML - Milliliter	0052-0301	e8dd0993-bc05-41ed-b13e-de563b514d8b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ganirelix Acetate	ACTIVE INGREDIENT	56U7906FQW	GANIRELIX ACETATE INJECTION, SOLUTION [ORGANON USA INC.]	9
ganirelix	ACTIVE MOIETY	IX503L9WN0	GANIRELIX ACETATE INJECTION, SOLUTION [ORGANON USA INC.]	9
acetic acid	INACTIVE INGREDIENT	Q40Q9N063P	GANIRELIX ACETATE INJECTION, SOLUTION [ORGANON USA INC.]	9
mannitol	INACTIVE INGREDIENT	3OWL53L36A	GANIRELIX ACETATE INJECTION, SOLUTION [ORGANON USA INC.]	9
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	GANIRELIX ACETATE INJECTION, SOLUTION [ORGANON USA INC.]	9
water	INACTIVE INGREDIENT	059QF0KO0R	GANIRELIX ACETATE INJECTION, SOLUTION [ORGANON USA INC.]	9

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ganirelix Acetate	GANIRELIX ACETATE	Organon LLC	32fb74ff-993a-49fe-8943-e029372b863e	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021057 application number: NDA021057

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
56U7906FQW	GANIRELIX ACETATE	129311-55-3	GANIRELIX ACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0052-0301-51	00052030151	1 BLISTER PACK in 1 CARTON (0052-0301-51) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS	1 blister pack	1999-07-29	0000-00-00	No	No	Current
0052-0301-81	00052030181	1 BLISTER PACK in 1 CARTON (0052-0301-81) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS	1 blister pack	1999-07-29	0000-00-00	No	No	Current