Lupron Depot

Product NDC: 0074-3663
11-digit product format: 000743663
Labeler code: 0074
Product ID: 0074-3663_fef36994-8fde-4b22-99a9-aa850c147eee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: leuprolide acetate
Dosage form: KIT
Labeler: AbbVie Inc.
Application: NDA020708
Marketing category: NDA
Marketing start: 2010-11-08
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020708-001	LUPRON DEPOT	LEUPROLIDE ACETATE	11.25MG	INJECTABLE / INJECTION		RLD, RS	1997-03-07

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020708-001	LUPRON DEPOT	11.25MG	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020708-001	LUPRON DEPOT	11.25MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1997-03-07	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lupron Depot
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
1115472	Internal RxNorm lookup
1115473	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
60aad237-e1da-4705-cbbb-b3ca79e89ad8	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
0074-3663-03	Lupron Depot	1 in 1 CARTON	KIT	1		1517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0074-3663-03	EA - Each	0074-3663	4408cf6c-86ba-4dc6-bc39-baae6e4b9b2a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1450
LEUPROLIDE ACETATE	ACTIVE INGREDIENT	37JNS02E7V	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1450
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1450
LEUPROLIDE	ACTIVE MOIETY	EFY6W0M8TG	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1450
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1450

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0074-3663	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1515	Current NDC, Legacy NDC, 1 package rows	20241207_60aad237-e1da-4705-cbbb-b3ca79e89ad8.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
Lupron Depot	LEUPROLIDE ACETATE	AbbVie Inc.	60aad237-e1da-4705-cbbb-b3ca79e89ad8	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020708 application number: NDA020708 ndc (product): 0074-3663

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
1115472	leuprolide acetate 11.25 MG in 1.5 ML (3 month) Prefilled Syringe	PSN	60aad237-e1da-4705-cbbb-b3ca79e89ad8	1517
1115473	Lupron Depot 11.25 MG in 1.5 ML (3 month) Prefilled Syringe	PSN	60aad237-e1da-4705-cbbb-b3ca79e89ad8	1517
1115473	1.5 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe [Lupron]	SBD	60aad237-e1da-4705-cbbb-b3ca79e89ad8	1517
1115472	1.5 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe	SCD	60aad237-e1da-4705-cbbb-b3ca79e89ad8	1517
1115473	1.5 ML Lupron Depot 7.5 MG/ML Prefilled Syringe	SY	60aad237-e1da-4705-cbbb-b3ca79e89ad8	1517
1115472	leuprolide acetate 11.25 MG per 1.5 ML (3 month) Prefilled Syringe	SY	60aad237-e1da-4705-cbbb-b3ca79e89ad8	1517
1115472	leuprolide acetate 11.25 MG per 1.5 ML Prefilled Syringe	SY	60aad237-e1da-4705-cbbb-b3ca79e89ad8	1517
1115473	Lupron Depot 11.25 MG per 1.5 ML (3 month) Prefilled Syringe	SY	60aad237-e1da-4705-cbbb-b3ca79e89ad8	1517

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0074-3663-03	00074366303	1 KIT in 1 CARTON (0074-3663-03) * 1.5 mL in 1 SYRINGE * 1 mL in 1 PACKET	1 kit	2010-11-08	0000-00-00	No	No	Current