Ganirelix Acetate

Product NDC: 70748-274
11-digit product format: 707480274
Labeler code: 70748
Product ID: 70748-274_c0fdd470-a16f-41c4-9bfa-4240b6ff67e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ganirelix Acetate
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA216075
Marketing category: ANDA
Marketing start: 2024-02-14
Substance: GANIRELIX ACETATE
Active strength: 250 ug/.5mL
Pharmacologic classes: Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA]
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 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
A216075-001	GANIRELIX ACETATE	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP		2023-11-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216075-001	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
2026-08-18 06:07:40	2026-07	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216075-001	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE / INJECTION	AP	2023-11-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A216075-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216075-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216075-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216075-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216075-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216075-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216075-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216075-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216075-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216075-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216075-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216075-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216075-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216075-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216075-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216075-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216075-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216075-001	AP	1	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216075-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ganirelix Acetate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GANIRELIX ACETATE	250 ug/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
56U7906FQW	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855200	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e50888ef-5e66-4b15-bdc3-2f6794f09246	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1a687bc4-8d90-54b3-7bbb-399cd21f76f1	Product name	5	20260209
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70748-274-01	Ganirelix Acetate	1 in 1 CARTON	INJECTION, SOLUTION	1		8
70748-274-01	Ganirelix Acetate	1 in 1 TRAY	INJECTION, SOLUTION	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70748-274-01	ML - Milliliter	70748-274	d3585eb3-6241-42bb-9b5b-d5f74183ae6b	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70748-274	GANIRELIX ACETATE INJECTION, SOLUTION [LUPIN PHARMACEUTICALS, INC.]	7	Current NDC, 2 package rows	20250322_e50888ef-5e66-4b15-bdc3-2f6794f09246.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ganirelix Acetate	GANIRELIX ACETATE	Lupin Pharmaceuticals, Inc.	e50888ef-5e66-4b15-bdc3-2f6794f09246	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216075 application number: ANDA216075 ndc (product): 70748-274

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855200	ganirelix acetate 250 MCG in 0.5 ML Prefilled Syringe	PSN	e50888ef-5e66-4b15-bdc3-2f6794f09246	8
855200	0.5 ML ganirelix acetate 0.5 MG/ML Prefilled Syringe	SCD	e50888ef-5e66-4b15-bdc3-2f6794f09246	8
855200	ganirelix acetate 0.5 MG/ML 0.5 ML Prefilled Syringe	SY	e50888ef-5e66-4b15-bdc3-2f6794f09246	8
855200	ganirelix acetate 250 MCG per 0.5 ML Prefilled Syringe	SY	e50888ef-5e66-4b15-bdc3-2f6794f09246	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70748-274-01	70748027401	1 TRAY in 1 CARTON (70748-274-01) / 1 SYRINGE, GLASS in 1 TRAY / 1 mL in 1 SYRINGE, GLASS	1 tray	2024-02-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GANIRELIX ACETATE INJECTION 250 mcg/0.5 mL For Subcutaneous Use Only Rx Only	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2025-09-03	HUMAN PRESCRIPTION DRUG LABEL	8