Home NDC 62935-756 Eligard
Product NDC 62935-756
11-digit product format 629350756
Labeler code 62935
Product ID 62935-756_58cff066-4345-4624-8868-4c232a051a5d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Leuprolide acetate
Dosage form INJECTION, SUSPENSION, EXTENDED RELEASE
Route SUBCUTANEOUS
Labeler TOLMAR Inc.
Application NDA021343
Marketing category NDA
Marketing start 2023-11-01
Substance LEUPROLIDE ACETATE
Active strength 7.5 mg/.25mL
Pharmacologic classes Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 N021343-001 ELIGARD KIT LEUPROLIDE ACETATE 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 N021343-001 11931559 2041-12-22 Drug substance 2024-04-15 N021343-001 12397120 2041-12-22 U-4001 2025-09-22
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021343-001 ELIGARD 7.5MG/VIAL INJECTABLE / SUBCUTANEOUS RLD, RS 2002-01-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021343-001 ELIGARD 7.5MG/VIAL INJECTABLE / SUBCUTANEOUS RLD, RS 2002-01-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021343-001 ELIGARD 7.5MG/VIAL INJECTABLE / SUBCUTANEOUS RLD, RS 2002-01-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021343-001 ELIGARD 7.5MG/VIAL INJECTABLE / SUBCUTANEOUS RLD, RS 2002-01-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021343-001 ELIGARD KIT 7.5MG POWDER / SUBCUTANEOUS RLD, RS 2002-01-23 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 43 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 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021343-001 11931559 2041-12-22 Drug substance 2024-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021343-001 12397120 2041-12-22 U-4001 2025-09-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021343-001 11931559 2041-12-22 Drug substance 2024-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021343-001 12397120 2041-12-22 U-4001 2025-09-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021343-001 11931559 2041-12-22 Drug substance 2024-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021343-001 11931559 2041-12-22 Drug substance 2024-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021343-001 11931559 2041-12-22 Drug substance 2024-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021343-001 11931559 2041-12-22 Drug substance 2024-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021343-001 11931559 2041-12-22 Drug substance 2024-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021343-001 11931559 2041-12-22 Drug substance 2024-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021343-001 11931559 2041-12-22 Drug substance 2024-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021343-001 11931559 2041-12-22 Drug substance 2024-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021343-001 11931559 2041-12-22 Drug substance 2024-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021343-001 11931559 2041-12-22 Drug substance 2024-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021343-001 11931559 2041-12-22 Drug substance 2024-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021343-001 11931559 2041-12-22 Drug substance 2024-04-15 8072bd15b7f6…2019-12-13 00:20 UTC 2019-12 N021343-001 6626870 2020-03-27 Drug product 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021343-001 6626870 2020-03-27 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021343-001 6626870 2020-03-27 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021343-001 6626870 2020-03-27 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021343-001 6626870 2020-03-27 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021343-001 6626870 2020-03-27 Drug product ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021343-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 a72a2bbeb626…
Additional Listing Data#
Finished product Yes
Brand name base Eligard
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEUPROLIDE ACETATE 7.5 mg/.25mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 37JNS02E7V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 752884 Internal RxNorm lookup 752889 Internal RxNorm lookup 752894 Internal RxNorm lookup 752899 Internal RxNorm lookup 825325 Internal RxNorm lookup 825333 Internal RxNorm lookup 825334 Internal RxNorm lookup 825335 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 62935-756-80 Eligard 0.25 mL in 1 SYRINGE INJECTION, SUSPENSION, EXTENDED 0.25 19 62935-756-80 Eligard 1 in 1 CARTON INJECTION, SUSPENSION, EXTENDED 1 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62935-756 ELIGARD (LEUPROLIDE ACETATE) INJECTION, SUSPENSION, EXTENDED RELEASE [TOLMAR INC.] 18 Current NDC, 2 package rows 20250228_b7b679a9-6823-4ef8-8d31-3ab5058ffcfc.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62935-756-80 62935075680 1 SYRINGE in 1 CARTON (62935-756-80) / .25 mL in 1 SYRINGE 1 syringe 2023-11-01 No No Current