Home NDC 65162-750 Dutasteride
Product NDC 65162-750
11-digit product format 651620750
Labeler code 65162
Product ID 65162-750_d1ac003d-2e58-4a30-8072-8419e7ebb4c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dutasteride
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA203118
Marketing category ANDA
Marketing start 2015-11-02
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 A203118-001 DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203118-001 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 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203118-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 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 2026-12-31 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 65162-750-03 Dutasteride 30 in 1 BOTTLE CAPSULE 30 14 65162-750-09 Dutasteride 90 in 1 BOTTLE CAPSULE 90 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DUTASTERIDE ACTIVE INGREDIENT O0J6XJN02I DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 DUTASTERIDE ACTIVE MOIETY O0J6XJN02I DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 GELATIN INACTIVE INGREDIENT 2G86QN327L DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 GLYCERYL CAPRYLATE/CAPRATE INACTIVE INGREDIENT G7515SW10N DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 WATER INACTIVE INGREDIENT 059QF0KO0R DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-750 DUTASTERIDE CAPSULE [AMNEAL PHARMACEUTICALS LLC] 14 Current NDC, Legacy NDC, 2 package rows 20241027_e537c60d-9ba2-4e7f-a405-2b915dcd7ead.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 Units Marketing start Marketing end Sample Exclude flag Status 65162-750-03 65162075003 30 CAPSULE in 1 BOTTLE (65162-750-03) 30 capsule 2015-11-02 0000-00-00 No No Current 65162-750-09 65162075009 90 CAPSULE in 1 BOTTLE (65162-750-09) 90 capsule 2015-11-02 0000-00-00 No No Current