Home DailyMed 3bc76bd0-9401-4e75-94a8-8950fbc9eee5 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:33:25 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 TE codes 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DEPOT-PED KIT LEUPROLIDE ACETATE 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAMUSCULAR RLD 1993-04-16 N020263-004 LUPRON DEPOT-PED KIT LEUPROLIDE ACETATE 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAMUSCULAR RLD 1993-04-16 N020263-005 LUPRON DEPOT-PED KIT LEUPROLIDE ACETATE 11.25MG POWDER / INTRAMUSCULAR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 9 · 325 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 2026-09-14 22:38:34 2026-08 N020263-002 LUPRON DEPOT-PED KIT 7.5MG POWDER / INTRAMUSCULAR RLD, RS 1993-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020263-005 LUPRON DEPOT-PED KIT 11.25MG POWDER / INTRAMUSCULAR RLD, RS 1994-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020263-006 LUPRON DEPOT-PED KIT 15MG POWDER / INTRAMUSCULAR RLD, RS 1994-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020263-007 LUPRON DEPOT-PED KIT 11.25MG POWDER / INTRAMUSCULAR RLD, RS 2011-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020263-008 LUPRON DEPOT-PED KIT 30MG POWDER / INTRAMUSCULAR RLD, RS 2011-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020263-009 LUPRON DEPOT-PED KIT 45MG POWDER / INTRAMUSCULAR RLD, RS 2023-04-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020263-002 LUPRON DEPOT-PED KIT 7.5MG POWDER / INTRAMUSCULAR RLD, RS 1993-04-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020263-005 LUPRON DEPOT-PED KIT 11.25MG POWDER / INTRAMUSCULAR RLD, RS 1994-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020263-006 LUPRON DEPOT-PED KIT 15MG POWDER / INTRAMUSCULAR RLD, RS 1994-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020263-007 LUPRON DEPOT-PED KIT 11.25MG POWDER / INTRAMUSCULAR RLD, RS 2011-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020263-008 LUPRON DEPOT-PED KIT 30MG POWDER / INTRAMUSCULAR RLD, RS 2011-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020263-009 LUPRON DEPOT-PED KIT 45MG POWDER / INTRAMUSCULAR RLD, RS 2023-04-14 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 2 · 48 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N020263-009 9617303 2028-03-22 U-3611 2023-05-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020263-009 8921326 2031-02-05 Drug product 2023-05-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020263-009 9617303 2028-03-22 U-3611 2023-05-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020263-009 8921326 2031-02-05 Drug product 2023-05-12 caaa826d4ba7…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…
Observed Orange Book exclusivity history# 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.