Home NDC 50090-7852 Dutasteride
Product NDC 50090-7852
11-digit product format 500907852
Labeler code 50090
Product ID 50090-7852_067a71d1-2d8f-4ca2-acb9-06718a5eb8c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dutasteride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA209909
Marketing category ANDA
Marketing start 2017-11-28
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 2027-12-31
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 A209909-001 DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209909-001 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 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209909-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-11-21 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 50090-7852-0 Dutasteride 30 in 1 BOTTLE CAPSULE, LIQUID FILLED 30 3 50090-7852-1 Dutasteride 90 in 1 BOTTLE CAPSULE, LIQUID FILLED 90 3
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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50090-7852-0 50090785200 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7852-0) 2026-01-08 No No Current 50090-7852-1 50090785201 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7852-1) 2026-01-08 No No Current