Lupron Depot-PED

Product NDC: 0074-3575
11-digit product format: 000743575
Labeler code: 0074
Product ID: 0074-3575_24e33d5f-c64b-4d45-a5ae-e18a1f696cfa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: leuprolide acetate
Dosage form: KIT
Labeler: AbbVie Inc.
Application: NDA020263
Marketing category: NDA
Marketing start: 2023-04-14
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 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020263-002	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	7.5MG	POWDER / INTRAMUSCULAR	RLD, RS	1993-04-16
N020263-003	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	3.75MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16
N020263-004	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16
N020263-005	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21
N020263-006	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	15MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21
N020263-007	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15
N020263-008	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	30MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15
N020263-009	LUPRON DEPOT-PED KIT	LEUPROLIDE ACETATE	45MG	POWDER / INTRAMUSCULAR	RLD, RS	2023-04-14

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N020263-009	9617303	2028-03-22	U-3611		2023-05-12
N020263-009	8921326	2031-02-05		Drug product	2023-05-12

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N020263-009	NS	2026-04-14

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 8 · 309 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	N020263-002	LUPRON DEPOT-PED KIT	7.5MG	POWDER / INTRAMUSCULAR	RLD, RS	1993-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-003	LUPRON DEPOT-PED KIT	3.75MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-004	LUPRON DEPOT-PED KIT	7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-005	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-006	LUPRON DEPOT-PED KIT	15MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-007	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-008	LUPRON DEPOT-PED KIT	30MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-009	LUPRON DEPOT-PED KIT	45MG	POWDER / INTRAMUSCULAR	RLD, RS	2023-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-002	LUPRON DEPOT-PED KIT	7.5MG	POWDER / INTRAMUSCULAR	RLD, RS	1993-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-003	LUPRON DEPOT-PED KIT	3.75MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-004	LUPRON DEPOT-PED KIT	7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-005	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-006	LUPRON DEPOT-PED KIT	15MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-007	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-008	LUPRON DEPOT-PED KIT	30MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-009	LUPRON DEPOT-PED KIT	45MG	POWDER / INTRAMUSCULAR	RLD, RS	2023-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020263-002	LUPRON DEPOT-PED KIT	7.5MG	POWDER / INTRAMUSCULAR	RLD, RS	1993-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-003	LUPRON DEPOT-PED KIT	3.75MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-004	LUPRON DEPOT-PED KIT	7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-005	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-006	LUPRON DEPOT-PED KIT	15MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-007	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-008	LUPRON DEPOT-PED KIT	30MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-009	LUPRON DEPOT-PED KIT	45MG	POWDER / INTRAMUSCULAR	RLD, RS	2023-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-002	LUPRON DEPOT-PED KIT	7.5MG	POWDER / INTRAMUSCULAR	RLD, RS	1993-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-003	LUPRON DEPOT-PED KIT	3.75MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-004	LUPRON DEPOT-PED KIT	7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-005	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-006	LUPRON DEPOT-PED KIT	15MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-007	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-008	LUPRON DEPOT-PED KIT	30MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-009	LUPRON DEPOT-PED KIT	45MG	POWDER / INTRAMUSCULAR	RLD, RS	2023-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-002	LUPRON DEPOT-PED KIT	7.5MG	POWDER / INTRAMUSCULAR	RLD, RS	1993-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-003	LUPRON DEPOT-PED KIT	3.75MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-004	LUPRON DEPOT-PED KIT	7.5MG,7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR	RLD	1993-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-005	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-006	LUPRON DEPOT-PED KIT	15MG	POWDER / INTRAMUSCULAR	RLD, RS	1994-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-007	LUPRON DEPOT-PED KIT	11.25MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-008	LUPRON DEPOT-PED KIT	30MG	POWDER / INTRAMUSCULAR	RLD, RS	2011-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-009	LUPRON DEPOT-PED KIT	45MG	POWDER / INTRAMUSCULAR	RLD, RS	2023-04-14	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020263-009	9617303	2028-03-22	U-3611		2023-05-12	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020263-009	8921326	2031-02-05		Drug product	2023-05-12	`a67488948f0b…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020263-009	NS	2026-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020263-009	NS	2026-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020263-009	NS	2026-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020263-009	NS	2026-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020263-009	NS	2026-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020263-009	NS	2026-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020263-009	NS	2026-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020263-009	NS	2026-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020263-009	NS	2026-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020263-009	NS	2026-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020263-009	NS	2026-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020263-009	NS	2026-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020263-009	NS	2026-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020263-009	NS	2026-04-14	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020263-009	NS	2026-04-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020263-009	NS	2026-04-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020263-009	NS	2026-04-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020263-009	NS	2026-04-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020263-009	NS	2026-04-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020263-009	NS	2026-04-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020263-009	NS	2026-04-14	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020263-009	NS	2026-04-14	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lupron Depot-PED
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1115447	Internal RxNorm lookup
1115449	Internal RxNorm lookup
1115454	Internal RxNorm lookup
1115456	Internal RxNorm lookup
1946519	Internal RxNorm lookup
1946520	Internal RxNorm lookup
2639668	Internal RxNorm lookup
2639669	Internal RxNorm lookup
2639742	Internal RxNorm lookup
2639743	Internal RxNorm lookup
2639749	Internal RxNorm lookup
2639750	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
e99f47d2-da10-3127-ecb3-e5d942ae6e81	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
0074-3410-01	Lupron Depot-PED	1.5 mL in 1 SYRINGE	INJECTION, POWDER, LYOPHILIZED,	1.5 mL	45 mg in 1.5mL	97
0074-3575-01	Lupron Depot-PED	1 in 1 CARTON	KIT	1		97

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0074-3575-01	EA - Each	0074-3575	d0bac529-f3d2-4e69-81e1-a93b111f96fd	1	2023-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEUPROLIDE ACETATE	ACTIVE INGREDIENT	37JNS02E7V	LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	36
LEUPROLIDE	ACTIVE MOIETY	EFY6W0M8TG	LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	36
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	36
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	36
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	36
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	36
POLYLACTIDE	INACTIVE INGREDIENT	459TN2L5F5	LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	36
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	36
WATER	INACTIVE INGREDIENT	059QF0KO0R	LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0074-3575	LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]	93	Current NDC, 2 package rows	20241109_e99f47d2-da10-3127-ecb3-e5d942ae6e81.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-PED	LEUPROLIDE ACETATE	AbbVie Inc.	e99f47d2-da10-3127-ecb3-e5d942ae6e81	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020263 application number: NDA020263 ndc (product): 0074-3575

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
1115447	leuprolide acetate 11.25 MG in 1 ML (pediatric 1 month) Prefilled Syringe	PSN	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639749	leuprolide acetate 11.25 MG in 1.5 ML (pediatric 3 month) Prefilled Syringe	PSN	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1115454	leuprolide acetate 15 MG in 1 ML (pediatric 1 month) Prefilled Syringe	PSN	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1946519	leuprolide acetate 30 MG in 1.5 ML (pediatric 3 month) Prefilled Syringe	PSN	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639668	leuprolide acetate 45 MG in 1.5 ML (pediatric 6 month) Prefilled Syringe	PSN	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639742	leuprolide acetate 7.5 MG in 1 ML (pediatric 1 month) Prefilled Syringe	PSN	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1115449	LUPRON DEPOT-PED 11.25 MG in 1 ML (1 month) Prefilled Syringe	PSN	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639750	LUPRON DEPOT-PED 11.25 MG in 1.5 ML (3 month) Prefilled Syringe	PSN	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1115456	LUPRON DEPOT-PED 15 MG in 1 ML (1 month) Prefilled Syringe	PSN	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1946520	LUPRON DEPOT-PED 30 MG in 1.5 ML (3 month) Prefilled Syringe	PSN	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639669	LUPRON DEPOT-PED 45 MG in 1.5 ML (6 month) Prefilled Syringe	PSN	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639743	LUPRON DEPOT-PED 7.5 MG in 1 ML (1 month) Prefilled Syringe	PSN	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1115449	1 ML leuprolide acetate 11.25 MG/ML Prefilled Syringe [Lupron]	SBD	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1115456	1 ML leuprolide acetate 15 MG/ML Prefilled Syringe [Lupron]	SBD	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1946520	3-Month 1.5 ML leuprolide acetate 20 MG/ML Prefilled Syringe [Lupron]	SBD	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639743	Pediatric 1 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe [Lupron]	SBD	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639669	Pediatric 1.5 ML leuprolide acetate 30 MG/ML Prefilled Syringe [Lupron]	SBD	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639750	Pediatric 1.5 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe [Lupron]	SBD	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1115447	1 ML leuprolide acetate 11.25 MG/ML Prefilled Syringe	SCD	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1115454	1 ML leuprolide acetate 15 MG/ML Prefilled Syringe	SCD	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1946519	3-Month 1.5 ML leuprolide acetate 20 MG/ML Prefilled Syringe	SCD	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639742	Pediatric 1 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe	SCD	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639668	Pediatric 1.5 ML leuprolide acetate 30 MG/ML Prefilled Syringe	SCD	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639749	Pediatric 1.5 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe	SCD	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1115449	1 ML Lupron Depot 11.25 MG/ML Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1115456	1 ML Lupron Depot 15 MG/ML Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1946519	1.5 ML leuprolide acetate 20 MG/ML (3 month) Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1946520	1.5 ML Lupron Depot-Ped 20 MG/ML (3 month) Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1115447	leuprolide acetate 11.25 MG per 1 ML (pediatric 1 month) Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1115447	leuprolide acetate 11.25 MG per 1 ML Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639749	leuprolide acetate 11.25 MG per 1.5 ML (pediatric 3 month) Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1115454	leuprolide acetate 15 MG per 1 ML (pediatric 1 month) Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1115454	leuprolide acetate 15 MG per 1 ML Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1946519	leuprolide acetate 30 MG per 1.5 ML (pediatric 3 month) Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639668	leuprolide acetate 45 MG per 1.5 ML (pediatric 6 month) Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639742	leuprolide acetate 7.5 MG per 1 ML (pediatric 1 month) Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639750	Lupron Depot Pediatric 11.25 MG per 1.5 ML (3 month) Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639669	Lupron Depot Pediatric 45 MG per 1.5 ML (6 month) Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639743	Lupron Depot Pediatric 7.5 MG per 1 ML (1 month) Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1115449	Lupron Depot-Ped 11.25 MG per 1 ML (1 month) Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1115456	Lupron Depot-Ped 15 MG per 1 ML (1 month) Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
1946520	Lupron Depot-Ped 30 MG per 1.5 ML (3 month) Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639669	Pediatric Lupron 30 MG/ML Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97
2639743	Pediatric Lupron 7.5 MG/ML Prefilled Syringe	SY	e99f47d2-da10-3127-ecb3-e5d942ae6e81	97

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0074-3410-01	00074341001	1.5 mL in 1 SYRINGE	1.5 ml				Historical
0074-3575-01	00074357501	1 KIT in 1 CARTON (0074-3575-01) * 1.5 mL in 1 SYRINGE (0074-3410-01) * 2 SWAB in 1 PACKET (0074-0010-01)	1 kit	2023-04-14	No	No	Current