Home NDC 67253-191 bicalutamide
Product NDC 67253-191
11-digit product format 672530191
Labeler code 67253
Product ID 67253-191_0353c7a7-53e1-4628-8585-049afbc48c1b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bicalutamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dava Pharmaceuticals, Inc.
Application ANDA077973
Marketing category ANDA
Marketing start 2009-07-06
Marketing end 0000-00-00
Substance BICALUTAMIDE
Active strength 50 mg/1
Pharmacologic classes Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A077973-001 BICALUTAMIDE BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06
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 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077973-001 BICALUTAMIDE 50MG TABLET / ORAL 2009-07-06 e64feba35796…
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 67253-191-03 2026-01-06 These highlights do not include all the information needed to use Bicalutamide Tablets, USP safely and effectively. See full prescribing information for Bicalutamide Tablets, USP. Bicalutamide Tablets, USP for Oral use Initial U.S. Approval: 1995 67253-191-10 2026-01-06 These highlights do not include all the information needed to use Bicalutamide Tablets, USP safely and effectively. See full prescribing information for Bicalutamide Tablets, USP. Bicalutamide Tablets, USP for Oral use Initial U.S. Approval: 1995 67253-191-03 2019-10-21 These highlights do not include all the information needed to use Bicalutamide Tablets, USP safely and effectively. See full prescribing information for Bicalutamide Tablets, USP. Bicalutamide Tablets, USP for Oral use Initial U.S. Approval: 1995 67253-191-10 2019-10-21 These highlights do not include all the information needed to use Bicalutamide Tablets, USP safely and effectively. See full prescribing information for Bicalutamide Tablets, USP. Bicalutamide Tablets, USP for Oral use Initial U.S. Approval: 1995
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded bicalutamide ACTIVE INGREDIENT A0Z3NAU9DP BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] 1 bicalutamide ACTIVE MOIETY A0Z3NAU9DP BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] 1 crospovidone INACTIVE INGREDIENT 68401960MK BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] 1 hypromellose INACTIVE INGREDIENT 3NXW29V3WO BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] 1 polyethylene glycol INACTIVE INGREDIENT 3WJQ0SDW1A BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] 1 povidone INACTIVE INGREDIENT FZ989GH94E BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] 1 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67253-191 BICALUTAMIDE TABLET, FILM COATED [DAVA PHARMACEUTICALS, INC.] 1 Legacy NDC 20090814_59df7b06-81d0-423c-9e80-9014d424b64c.zip