Lupron Depot

Product NDC: 0074-3642
11-digit product format: 000743642
Labeler code: 0074
Product ID: 0074-3642_98a4f293-ee7c-44d0-9a1e-9dc7faf8aaf8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: leuprolide acetate
Dosage form: KIT
Labeler: AbbVie Inc.
Application: NDA019732
Marketing category: NDA
Marketing start: 1989-01-26
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
N019732-001	LUPRON DEPOT	LEUPROLIDE ACETATE	7.5MG	INJECTABLE / INJECTION		RLD, RS	1989-01-26

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	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019732-001	LUPRON DEPOT	7.5MG	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019732-001	LUPRON DEPOT	7.5MG/VIAL	INJECTABLE / INJECTION	RLD, RS	1989-01-26	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lupron Depot
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1115257	Internal RxNorm lookup
1115259	Internal RxNorm lookup
1115462	Internal RxNorm lookup
1115464	Internal RxNorm lookup
1115467	Internal RxNorm lookup
1115468	Internal RxNorm lookup
1946521	Internal RxNorm lookup
1946522	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
cbc8f94e-7330-4465-05ad-16d64493a5dd	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
0074-3642-03	Lupron Depot	1 in 1 CARTON	KIT	1		1542

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0074-3642-03	EA - Each	0074-3642	0dd4d102-b709-48d1-9258-be1f2ed5d5ab	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEUPROLIDE ACETATE	ACTIVE INGREDIENT	37JNS02E7V	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1488
LEUPROLIDE	ACTIVE MOIETY	EFY6W0M8TG	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1488
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1488
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1488
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1488
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1488
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1488
POLYLACTIDE	INACTIVE INGREDIENT	459TN2L5F5	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1488
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1488
WATER	INACTIVE INGREDIENT	059QF0KO0R	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1488

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0074-3642	LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	1540	Current NDC, Legacy NDC, 1 package rows	20240606_cbc8f94e-7330-4465-05ad-16d64493a5dd.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.	cbc8f94e-7330-4465-05ad-16d64493a5dd	2026-03-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019732 application number: NDA019732 ndc (product): 0074-3642

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
1115467	leuprolide acetate 22.5 MG in 1.5 ML (3 month) Prefilled Syringe	PSN	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1946521	leuprolide acetate 30 MG in 1.5 ML (4 month) Prefilled Syringe	PSN	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115257	leuprolide acetate 45 MG in 1.5 ML (6 month) Prefilled Syringe	PSN	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115462	leuprolide acetate 7.5 MG in 1 ML (1 month) Prefilled Syringe	PSN	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115468	Lupron Depot 22.5 MG in 1.5 ML (3 month) Prefilled Syringe	PSN	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1946522	Lupron Depot 30 MG in 1.5 ML (4 month) Prefilled Syringe	PSN	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115259	Lupron Depot 45 MG in 1.5 ML (6 month) Prefilled Syringe	PSN	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115464	Lupron Depot 7.5 MG in 1 ML (1 month) Prefilled Syringe	PSN	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115464	1 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe [Lupron]	SBD	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115468	1.5 ML leuprolide acetate 15 MG/ML Prefilled Syringe [Lupron]	SBD	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115259	1.5 ML leuprolide acetate 30 MG/ML Prefilled Syringe [Lupron]	SBD	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1946522	4-Month 1.5 ML leuprolide acetate 20 MG/ML Prefilled Syringe [Lupron]	SBD	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115462	1 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe	SCD	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115467	1.5 ML leuprolide acetate 15 MG/ML Prefilled Syringe	SCD	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115257	1.5 ML leuprolide acetate 30 MG/ML Prefilled Syringe	SCD	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1946521	4-Month 1.5 ML leuprolide acetate 20 MG/ML Prefilled Syringe	SCD	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115464	1 ML Lupron 7.5 MG/ML Prefilled Syringe	SY	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1946521	1.5 ML leuprolide acetate 20 MG/ML (4 month) Prefilled Syringe	SY	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115468	1.5 ML Lupron 15 MG/ML Prefilled Syringe	SY	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115259	1.5 ML Lupron 30 MG/ML Prefilled Syringe	SY	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1946522	1.5 ML Lupron Depot 20 MG/ML (4 month) Prefilled Syringe	SY	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115467	leuprolide acetate 15 MG/ML 1.5 ML (3 month) Prefilled Syringe	SY	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115467	leuprolide acetate 15 MG/ML 1.5 ML Prefilled Syringe	SY	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1946521	leuprolide acetate 30 MG per 1.5 ML (4 month) Prefilled Syringe	SY	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115257	leuprolide acetate 45 MG per 1.5 ML (6 month) Prefilled Syringe	SY	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115462	leuprolide acetate 7.5 MG per 1 ML (1 month) Prefilled Syringe	SY	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115468	Lupron Depot 22.5 MG per 1.5 ML (3 month) Prefilled Syringe	SY	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115259	Lupron Depot 45 MG per 1.5 ML (6 month) Prefilled Syringe	SY	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542
1115464	Lupron Depot 7.5 MG per 1 ML (1 month) Prefilled Syringe	SY	cbc8f94e-7330-4465-05ad-16d64493a5dd	1542

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0074-3642-03	00074364203	1 KIT in 1 CARTON (0074-3642-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET	1 kit	1989-01-27	0000-00-00	No	No	Current
0074-3642-55	00074364255	1 KIT in 1 CELLO PACK (0074-3642-55) * 1 mL in 1 SYRINGE (0074-9907-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET	1 kit	2026-03-15		0		Current