Home NDC 67979-002 SUPPRELIN
Product NDC 67979-002
11-digit product format 679790002
Labeler code 67979
Product ID 67979-002_917e915f-4793-48bf-84c3-50272421616f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name histrelin acetate
Dosage form IMPLANT
Route SUBCUTANEOUS
Labeler Endo USA, Inc.
Application NDA022058
Marketing category NDA
Marketing start 2007-05-31
Substance HISTRELIN ACETATE
Active strength 50 mg/1
Pharmacologic classes Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
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 N022058-001 SUPPRELIN LA HISTRELIN ACETATE 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022058-001 8062652 2026-06-16 U-1197
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 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022058-001 SUPPRELIN LA 50MG IMPLANT / SUBCUTANEOUS RLD, RS 2007-05-03 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base SUPPRELIN
Brand name suffix LA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HISTRELIN ACETATE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QMG7HLD1ZE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1294641 Internal RxNorm lookup 1740437 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 67979-002-01 SUPPRELINLA 1 in 1 VIAL, GLASS IMPLANT 1 38 67979-002-01 SUPPRELINLA 1 in 1 CARTON IMPLANT 1 38
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67979-002 SUPPRELIN LA (HISTRELIN ACETATE) IMPLANT [ENDO USA, INC.] 36 Current NDC, Legacy NDC, 2 package rows 20240425_d8fb000e-3cc9-4803-b71d-2cc597661977.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 Marketing start Marketing end Sample Exclude flag Status 67979-002-01 67979000201 1 VIAL, GLASS in 1 CARTON (67979-002-01) / 1 IMPLANT in 1 VIAL, GLASS 2007-05-31 0000-00-00 No No Current