Home NDC 84091-100 DUTASTERIDE
Product NDC 84091-100
11-digit product format 840910100
Labeler code 84091
Product ID 84091-100_372f7766-bcc0-4eaa-8593-e29c0c6dcff7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DUTASTERIDE
Dosage form CAPSULE
Route ORAL
Labeler Banyan Pharma LLC
Application ANDA204705
Marketing category ANDA
Marketing start 2025-12-31
Substance DUTASTERIDE
Active strength .5 mg/1
Pharmacologic classes 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
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 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 A204705-001 DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20
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 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204705-001 DUTASTERIDE 0.5MG CAPSULE / ORAL 2015-11-20 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base DUTASTERIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DUTASTERIDE .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O0J6XJN02I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 351172 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 84091-100-90 DUTASTERIDE 90 in 1 BOTTLE CAPSULE 90 2
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84091-100-90 84091010090 90 CAPSULE in 1 BOTTLE (84091-100-90) 90 capsule 2025-12-31 No No Current