leuprolide acetate

Product NDC: 72843-591
Requested package NDC: 72843-591-99
11-digit product format: 728430591
Labeler code: 72843
Product ID: 72843-591_4e3665c7-c296-c3d1-e063-6294a90ada86
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: leuprolide acetate
Dosage form: KIT
Route: SUBCUTANEOUS
Labeler: UBI Pharma Inc.
Application: ANDA217957
Marketing category: ANDA
Marketing start: 2024-10-25
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A217957-001	LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP		2024-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217957-001	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
2026-09-14 22:38:34	2026-08	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217957-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217957-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217957-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217957-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217957-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217957-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217957-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217957-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217957-001	AP	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217957-001	AP	1	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217957-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: leuprolide acetate
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
545835	Internal RxNorm lookup
797544	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
cd46628f-055f-4da9-8c38-fa69af34eb4d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e666f57-491f-16e0-fc75-cc1c9f2fe06f	Product name	4	20250515
43944b95-6cc2-4eca-846a-a5e0ed070616	Product name	1	20240501
f3ff4518-37fe-47a0-8a1e-6ce032a3efd5	Product name	1	20230829
2ed2d111-4d16-4e2a-9b09-7d196056f6c9	Product name	1	20211214
ce98e98f-fa6b-48a6-8ad2-9ef8e8098f26	Product name	1	20200925
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
23ede539-308f-46e5-817b-41ef23af8d40	Product name	1	20150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4d	Product name	1	20150930
ae18ed71-8057-40ec-987f-83624e50b906	Product name	1	20150122
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
72843-590-01	leuprolide acetate	1 in 1 CARTON	INJECTION, SOLUTION		5 mg in 1mL	6
72843-590-01	leuprolide acetate	2.8 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	2.8 mL	5 mg in 1mL	6
72843-591-99	leuprolide acetate	1 in 1 CARTON	KIT	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72843-591	LEUPROLIDE ACETATE KIT [UBI PHARMA INC.]	2	Current NDC, 3 package rows	20241027_cd46628f-055f-4da9-8c38-fa69af34eb4d.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
leuprolide acetate	LEUPROLIDE ACETATE	UBI Pharma Inc.	cd46628f-055f-4da9-8c38-fa69af34eb4d	2026-03-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217957 application number: ANDA217957 ndc (package): 72843-591-99 ndc (product): 72843-591 ndc11 (package): 72843059199
leuprolide acetate	LEUPROLIDE ACETATE	PAI Holdings, LLC dba PAI Pharma	19be0b7f-e68a-4547-9e49-b51b12821907	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217957 application number: ANDA217957

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
37JNS02E7V	LEUPROLIDE ACETATE	74381-53-6	leuprolide acetate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
797544	isopropyl alcohol 70 % Medicated Pad	PSN	cd46628f-055f-4da9-8c38-fa69af34eb4d	6
545835	leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution	PSN	cd46628f-055f-4da9-8c38-fa69af34eb4d	6
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	cd46628f-055f-4da9-8c38-fa69af34eb4d	6
545835	leuprolide acetate 5 MG/ML Injectable Solution	SCD	cd46628f-055f-4da9-8c38-fa69af34eb4d	6
797544	isopropyl alcohol 70 % Medicated Pad	SY	cd46628f-055f-4da9-8c38-fa69af34eb4d	6
797544	isopropyl alcohol 70 % Topical Cloth	SY	cd46628f-055f-4da9-8c38-fa69af34eb4d	6
797544	isopropyl alcohol 70 % Topical Swab	SY	cd46628f-055f-4da9-8c38-fa69af34eb4d	6
545835	leuprolide acetate 1 MG per 0.2 ML Injectable Solution	SY	cd46628f-055f-4da9-8c38-fa69af34eb4d	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72843-591-99	72843059199	1 KIT in 1 CARTON (72843-591-99) * 1 VIAL, MULTI-DOSE in 1 CARTON (72843-590-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET	1 kit	2024-10-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leuprolide Acetate Injection (leuprolide acetate) Rx only	UBI Pharma Inc.	2026-03-29	HUMAN PRESCRIPTION DRUG LABEL	6