Bicalutamide

Product NDC
16714-571
11-digit product format
167140571
Labeler code
16714
Product ID
16714-571_963fe7a5-8c45-4071-8017-96f033a17d48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bicalutamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northstar RxLLC
Application
ANDA078634
Marketing category
ANDA
Marketing start
2009-08-28
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
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct16714-571DDiscontinued by firm2026-08-17
excluded packagepackage16714-57116714-571-01DDiscontinued by firm2026-08-17
excluded packagepackage16714-57116714-571-02DDiscontinued by firm2026-08-17
excluded packagepackage16714-57116714-571-03DDiscontinued by firm2026-08-17

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16714-571-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16714-571-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16714-571-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16714-571-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16714-571-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16714-571-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16714-571-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16714-571-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16714-571-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16714-571-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16714-571-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16714-571-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16714-571-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16714-571-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16714-571-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16714-571-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16714-571-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16714-571-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16714-571-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16714-571-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16714-571-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16714-571-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16714-571-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16714-571-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16714-571-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16714-571-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16714-571-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16714-571-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16714-571-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16714-571-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16714-571-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16714-571-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16714-571-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16714-571-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16714-571-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16714-571-03557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078634-001BICALUTAMIDEBICALUTAMIDE50MGTABLET / ORALAB2009-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A078634-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-283f01610625f2…
2019-09-15 20:21 UTC2019-09A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078634-001BICALUTAMIDE50MGTABLET / ORALAB2009-08-28e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078634-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078634-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078634-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078634-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078634-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078634-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078634-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078634-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078634-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078634-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078634-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078634-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078634-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078634-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078634-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078634-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078634-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078634-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078634-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078634-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078634-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078634-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078634-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078634-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078634-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078634-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078634-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078634-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078634-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078634-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078634-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078634-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078634-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078634-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078634-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078634-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078634-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078634-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078634-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078634-001AB1e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-571-01EA - Each16714-5712a35b673-e661-432b-8fd2-925cc23fd49512012-07-24
16714-571-02EA - Each16714-571417b9dc2-5fbe-4253-ac02-bca4bfccb5d612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BICALUTAMIDEACTIVE INGREDIENTA0Z3NAU9DPBICALUTAMIDE TABLET, FILM COATED [NORTHSTAR RXLLC]5
BICALUTAMIDEACTIVE MOIETYA0Z3NAU9DPBICALUTAMIDE TABLET, FILM COATED [NORTHSTAR RXLLC]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBICALUTAMIDE TABLET, FILM COATED [NORTHSTAR RXLLC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BICALUTAMIDE TABLET, FILM COATED [NORTHSTAR RXLLC]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBICALUTAMIDE TABLET, FILM COATED [NORTHSTAR RXLLC]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BICALUTAMIDE TABLET, FILM COATED [NORTHSTAR RXLLC]5
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQBICALUTAMIDE TABLET, FILM COATED [NORTHSTAR RXLLC]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BICALUTAMIDE TABLET, FILM COATED [NORTHSTAR RXLLC]5
TALCINACTIVE INGREDIENT7SEV7J4R1UBICALUTAMIDE TABLET, FILM COATED [NORTHSTAR RXLLC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBICALUTAMIDE TABLET, FILM COATED [NORTHSTAR RXLLC]5