Home NDC 72578-215 Bicalutamide
Product NDC 72578-215
11-digit product format 725780215
Labeler code 72578
Product ID 72578-215_7f9961d0-109d-4640-bedc-319663483652
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bicalutamide
Dosage form TABLET
Route ORAL
Labeler Viona Pharmaceuticals Inc.
Application ANDA079089
Marketing category ANDA
Marketing start 2009-06-07
Substance BICALUTAMIDE
Active strength 50 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 42 .
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 A079089-001 BICALUTAMIDE BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079089-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079089-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Bicalutamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BICALUTAMIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination A0Z3NAU9DP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199123 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 72578-215-01 Bicalutamide 100 in 1 BOTTLE TABLET 100 1 72578-215-06 Bicalutamide 30 in 1 BOTTLE TABLET 30 1
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 Sample Exclude flag Status 72578-215-01 72578021501 100 TABLET in 1 BOTTLE (72578-215-01) 100 tablet 2009-06-07 No No Current 72578-215-06 72578021506 30 TABLET in 1 BOTTLE (72578-215-06) 30 tablet 2009-06-07 No No Current