Home NDC 64380-763-05 Dutasteride
Product NDC 64380-763
Requested package NDC 64380-763-05
11-digit product format 643800763
Labeler code 64380
Product ID 64380-763_5a02c220-eebe-ba1b-e063-6394a90af2bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dutasteride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA204262
Marketing category ANDA
Marketing start 2016-12-09
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A204262-001 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 A204262-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204262-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2015-11-20 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 64380-763-04 2025-03-28 These highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001 64380-763-04 2025-03-28 These highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001 64380-763-05 2025-03-28 These highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001 64380-763-05 2025-03-28 These highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001 64380-763-04 2025-01-30 These highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001 64380-763-04 2025-01-30 These highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001 64380-763-05 2025-01-30 These highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001 64380-763-05 2025-01-30 These highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64380-763-05 64380076305 90 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (64380-763-05) 2016-12-10 0000-00-00 No No Current