Home NDC 59651-063 Dutasteride and Tamsulosin Hydrochloride
Product NDC 59651-063
11-digit product format 596510063
Labeler code 59651
Product ID 59651-063_2ad47033-76f3-447d-8a44-21479e9164c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dutasteride and Tamsulosin Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA213300
Marketing category ANDA
Marketing start 2024-07-18
Substance DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
Active strength .5; .4 mg/1; mg/1
Pharmacologic classes 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA], Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
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 A213300-001 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB 2024-07-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213300-001 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.
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 A213300-001 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB 2024-07-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213300-001 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB 2024-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213300-001 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB 2024-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213300-001 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB 2024-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213300-001 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB 2024-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213300-001 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB 2024-07-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213300-001 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB 2024-07-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213300-001 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB 2024-07-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213300-001 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB 2024-07-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213300-001 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB 2024-07-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213300-001 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB 2024-07-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213300-001 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB 2024-07-18 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213300-001 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB 2024-07-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Dutasteride and Tamsulosin Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DUTASTERIDE .5 mg/1 TAMSULOSIN HYDROCHLORIDE .4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O0J6XJN02I Internal UNII lookup 11SV1951MR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996097 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 59651-063-30 Dutasteride and Tamsulosin Hydrochloride 30 in 1 BOTTLE CAPSULE 30 1 59651-063-90 Dutasteride and Tamsulosin Hydrochloride 90 in 1 BOTTLE CAPSULE 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-063 DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED] 1 Current NDC, 2 package rows 20240725_2ad47033-76f3-447d-8a44-21479e9164c0.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 · 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 59651-063-30 59651006330 30 CAPSULE in 1 BOTTLE (59651-063-30) 30 capsule 2024-07-18 No No Current 59651-063-90 59651006390 90 CAPSULE in 1 BOTTLE (59651-063-90) 90 capsule 2024-07-18 No No Current