Home NDC 68382-224-10 Bicalutamide
Product NDC 68382-224
Requested package NDC 68382-224-10
11-digit product format 683820224
Labeler code 68382
Product ID 68382-224_e0e4d926-f498-4291-bfdb-37201e524374
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bicalutamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA079089
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 No
Listing certified through 2023-12-31
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 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BICALUTAMIDE ACTIVE INGREDIENT A0Z3NAU9DP BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5 BICALUTAMIDE ACTIVE MOIETY A0Z3NAU9DP BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5 AMINOLEVULINIC ACID HYDROCHLORIDE INACTIVE INGREDIENT V35KBM8JGR BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5 AMINOMETRADINE INACTIVE INGREDIENT PPM8SX5Q3V BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5 AMINOPHYLLINE INACTIVE INGREDIENT 27Y3KJK423 BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5 AMINOPROMAZINE INACTIVE INGREDIENT S9SDD93U5U BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5 AMINOPTERIN SODIUM INACTIVE INGREDIENT FZU1QI13O9 BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5 AMINOTHIAZOLE INACTIVE INGREDIENT 5K8WKN668K BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5 AMOPROXAN INACTIVE INGREDIENT 27RL57FCYM BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5 POVIDONE INACTIVE INGREDIENT FZ989GH94E BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BICALUTAMIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 5
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68382-224-10 68382022410 1000 TABLET, FILM COATED in 1 BOTTLE (68382-224-10) 2009-07-06 0000-00-00 No No Current