Home NDC 0074-3641 Lupron Depot
Product NDC 0074-3641
11-digit product format 000743641
Labeler code 0074
Product ID 0074-3641_691f9b76-b15b-47c9-8df9-8ebe91999b45
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name leuprolide acetate
Dosage form KIT
Labeler AbbVie Inc.
Application NDA020011
Marketing category NDA
Marketing start 1990-10-22
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020011-001 LUPRON DEPOT LEUPROLIDE ACETATE 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 N020011-002 LUPRON DEPOT LEUPROLIDE ACETATE 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26
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 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020011-001 LUPRON DEPOT 3.75MG/VIAL INJECTABLE / INJECTION RLD 1990-10-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020011-001 LUPRON DEPOT 3.75MG/VIAL INJECTABLE / INJECTION RLD 1990-10-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION RLD 1990-10-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION RLD 1990-10-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 782e0a99824c…
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 797544 Internal RxNorm lookup 1115457 Internal RxNorm lookup 1115459 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0074-3641-03 Lupron Depot 1 in 1 CARTON KIT 1 1478 0074-3641-71 Lupron Depot 1 in 1 CARTON KIT 1 1478
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0074-3641 LUPRON DEPOT (LEUPROLIDE ACETATE) KIT [ABBVIE INC.] 1476 Current NDC, Legacy NDC, 2 package rows 20241207_00c486b0-bd7b-4898-834d-8c656e5e73cb.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0074-3641-03 00074364103 1 KIT in 1 CARTON (0074-3641-03) * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 1 kit 1990-10-22 0000-00-00 No No Current 0074-3641-71 00074364171 1 KIT in 1 CARTON (0074-3641-71) * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET 1 kit 1990-10-22 0000-00-00 Yes No Current