Home NDC 47335-485 bicalutamide
Product NDC 47335-485
11-digit product format 473350485
Labeler code 47335
Product ID 47335-485_3259c219-2548-4ea5-b6ad-e22f249879c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bicalutamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA079110
Marketing category ANDA
Marketing start 2014-12-15
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 A079110-001 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 A079110-001 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 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079110-001 BICALUTAMIDE 50MG TABLET / ORAL AB 2009-07-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079110-001 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 47335-485-08 bicalutamide 100 in 1 BOTTLE TABLET, FILM COATED 100 8 47335-485-18 bicalutamide 1000 in 1 BOTTLE TABLET, FILM COATED 1000 8 47335-485-83 bicalutamide 30 in 1 BOTTLE TABLET, FILM COATED 30 8 47335-485-88 bicalutamide 100 in 1 BOTTLE TABLET, FILM COATED 100 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BICALUTAMIDE ACTIVE INGREDIENT A0Z3NAU9DP BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 1 BICALUTAMIDE ACTIVE MOIETY A0Z3NAU9DP BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BICALUTAMIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-485 BICALUTAMIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 Current NDC, Legacy NDC, 4 package rows 20250130_8b533fe4-287f-482c-b530-d9a5bf2ce40c.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 Marketing start Marketing end Sample Exclude flag Status 47335-485-08 47335048508 100 TABLET, FILM COATED in 1 BOTTLE (47335-485-08) 2014-12-15 0000-00-00 No No Current 47335-485-18 47335048518 1000 TABLET, FILM COATED in 1 BOTTLE (47335-485-18) 2014-12-15 0000-00-00 No No Current 47335-485-83 47335048583 30 TABLET, FILM COATED in 1 BOTTLE (47335-485-83) 2014-12-15 0000-00-00 No No Current 47335-485-88 47335048588 100 TABLET, FILM COATED in 1 BOTTLE (47335-485-88) 2014-12-15 0000-00-00 No No Current