Home NDC 62935-153 Fensolvi
Product NDC 62935-153
11-digit product format 629350153
Labeler code 62935
Product ID 62935-153_eeda0531-099b-4b55-b287-8c534c3bb5f0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Leuprolide Acetate
Dosage form KIT
Labeler TOLMAR Inc.
Application NDA213150
Marketing category NDA
Marketing start 2020-06-03
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 N213150-001 FENSOLVI KIT LEUPROLIDE ACETATE 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01
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 N213150-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 N213150-001 11931559 2041-12-22 Drug substance 2024-04-15 N213150-001 12397120 2041-12-22 U-3611 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.
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 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213150-001 FENSOLVI KIT 45MG POWDER / SUBCUTANEOUS RLD, RS 2020-05-01 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 61 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 N213150-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213150-001 11931559 2041-12-22 Drug substance 2024-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213150-001 12397120 2041-12-22 U-3611 2025-09-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213150-001 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 N213150-001 11931559 2041-12-22 Drug substance 2024-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213150-001 12397120 2041-12-22 U-3611 2025-09-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213150-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213150-001 11931559 2041-12-22 Drug substance 2024-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213150-001 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 N213150-001 11931559 2041-12-22 Drug substance 2024-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213150-001 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 N213150-001 11931559 2041-12-22 Drug substance 2024-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213150-001 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 N213150-001 11931559 2041-12-22 Drug substance 2024-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213150-001 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 N213150-001 11931559 2041-12-22 Drug substance 2024-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213150-001 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 N213150-001 11931559 2041-12-22 Drug substance 2024-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213150-001 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 N213150-001 11931559 2041-12-22 Drug substance 2024-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213150-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213150-001 11931559 2041-12-22 Drug substance 2024-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213150-001 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 N213150-001 11931559 2041-12-22 Drug substance 2024-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213150-001 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 N213150-001 11931559 2041-12-22 Drug substance 2024-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213150-001 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 N213150-001 11931559 2041-12-22 Drug substance 2024-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213150-001 11771841 2041-12-22 Drug substance, Drug product 2023-10-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213150-001 11931559 2041-12-22 Drug substance 2024-04-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213150-001 8470359 2023-10-15 U-2940 Drug substance, Drug product 2020-08-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213150-001 8470359 2023-10-15 U-2940 Drug substance, Drug product 2020-08-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213150-001 8470359 2023-10-15 U-2940 Drug substance, Drug product 2020-08-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213150-001 8470359 2023-10-15 U-2940 Drug substance, Drug product 2020-08-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213150-001 8470359 2023-10-15 U-2940 Drug substance, Drug product 2020-08-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213150-001 8470359 2023-10-15 U-2940 Drug substance, Drug product 2020-08-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213150-001 8470359 2023-10-15 U-2940 Drug substance, Drug product 2020-08-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213150-001 9539333 2020-11-13 Drug substance, Drug product 2020-08-28 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N213150-001 9914802 2020-11-13 U-2940 Drug substance, Drug product 2020-08-28 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N213150-001 8470359 2023-10-15 U-2940 Drug substance, Drug product 2020-08-28 8869cabd3fbd…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Fensolvi
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 752884 Internal RxNorm lookup 2371773 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 62935-153-50 Fensolvi 1 in 1 CARTON KIT 1 17 62935-154-50 Fensolvi 0.375 mL in 1 SYRINGE INJECTION, SUSPENSION, EXTENDED 0.375 mL 45 mg in 0.375mL 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62935-153 FENSOLVI (LEUPROLIDE ACETATE) KIT [TOLMAR INC.] 17 Current NDC, Legacy NDC, 2 package rows 20231206_dfb6e01c-f138-471d-bf5b-2be38247e3f0.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 · 2 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 62935-153-50 62935015350 1 KIT in 1 CARTON (62935-153-50) * .375 mL in 1 SYRINGE (62935-154-50) * .375 mL in 1 SYRINGE (62935-155-40) 1 kit 2020-06-03 0000-00-00 No No Current 62935-154-50 62935015450 0.375 mL in 1 SYRINGE 0.375 ml Historical