Home NDC 80725-600 Eulexin
Product NDC 80725-600
11-digit product format 807250600
Labeler code 80725
Product ID 80725-600_7c581273-b507-4c4b-bcda-fa67a21b1c56
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flutamide
Dosage form CAPSULE
Route ORAL
Labeler Waylis Therapeutics LLC
Application ANDA075298
Marketing category ANDA
Marketing start 2021-11-12
Substance FLUTAMIDE
Active strength 125 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 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# Additional Listing Data#
Finished product Yes
Brand name base Eulexin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUTAMIDE 125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 76W6J0943E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197726 Internal RxNorm lookup 205646 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 80725-600-18 Eulexin 1 in 1 BOX CAPSULE 1 2 80725-600-18 Eulexin 180 in 1 BOTTLE, PLASTIC CAPSULE 180 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80725-600 EULEXIN (FLUTAMIDE) CAPSULE [WAYLIS THERAPEUTICS LLC] 2 Current NDC, Legacy NDC, 2 package rows 20220115_56b6ba36-9b49-4422-a2a4-7bfa0d941a5d.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 80725-600-18 80725060018 1 BOTTLE, PLASTIC in 1 BOX (80725-600-18) / 180 CAPSULE in 1 BOTTLE, PLASTIC 2021-11-12 0000-00-00 No No Current