Home NDC 62559-173 Nilutamide
Product NDC 62559-173
11-digit product format 625590173
Labeler code 62559
Product ID 62559-173_441002fd-1e82-482c-acab-560838b7118f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nilutamide
Dosage form TABLET
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA207631
Marketing category ANDA
Marketing start 2016-07-18
Substance NILUTAMIDE
Active strength 150 mg/1
Pharmacologic classes Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
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 A207631-001 NILUTAMIDE NILUTAMIDE 150MG TABLET / ORAL RS 2016-07-15
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 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207631-001 NILUTAMIDE 150MG TABLET / ORAL AB 2016-07-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Nilutamide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NILUTAMIDE 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 51G6I8B902 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311982 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 62559-173-31 Nilutamide 10 in 1 BLISTER PACK TABLET 10 5 62559-173-31 Nilutamide 3 in 1 CARTON TABLET 3 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-173 NILUTAMIDE TABLET [ANI PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20200916_d5740b8f-fbb3-4023-9133-9e359a9ab980.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 62559-173-31 62559017331 3 BLISTER PACK in 1 CARTON (62559-173-31) / 10 TABLET in 1 BLISTER PACK 3 blister pack 2016-07-18 0000-00-00 No No Current