Home NDC 49884-753-13 Flutamide
Product NDC 49884-753
Requested package NDC 49884-753-13
11-digit product format 498840753
Labeler code 49884
Product ID 49884-753_0d184d29-fbaf-4d17-98bc-13852fc67a9e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flutamide
Dosage form CAPSULE
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application ANDA075298
Marketing category ANDA
Marketing start 2006-01-26
Marketing end 2023-08-31
Substance FLUTAMIDE
Active strength 125 mg/1
Pharmacologic classes Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 1 .
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 A075298-001 FLUTAMIDE FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL AB 2001-09-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL AB 2001-09-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL AB 2001-09-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL AB 2001-09-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL AB 2001-09-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL AB 2001-09-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL AB 2001-09-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075298-001 FLUTAMIDE 125MG CAPSULE / ORAL RS 2001-09-18 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# 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 Units Marketing start Marketing end Sample Exclude flag Status 49884-753-13 49884075313 180 CAPSULE in 1 BOTTLE (49884-753-13) 180 capsule 2006-01-26 2023-08-31 No No Current