Home NDC 68071-3757 Dutasteride
Product NDC 68071-3757
11-digit product format 680713757
Labeler code 68071
Product ID 68071-3757_2ad2f521-f578-01c4-e063-6394a90ac831
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dutasteride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
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 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 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 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 68071-3757-6 Dutasteride 60 in 1 BOTTLE CAPSULE, LIQUID FILLED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3757 DUTASTERIDE CAPSULE, LIQUID FILLED [NUCARE PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20250110_2ad309b1-4497-8b9b-e063-6394a90aa9b4.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 · 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 68071-3757-6 68071375706 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (68071-3757-6) 2025-01-03 No No Current