dutasteride and tamsulosin hydrochloride (68382-640)

Drug Facts

Product Profile

Brand Name dutasteride and tamsulosin hydrochloride

Generic Name dutasteride and tamsulosin hydrochloride

Labeler zydus pharmaceuticals usa inc.

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

dutasteride .5 mg/1, tamsulosin hydrochloride .4 mg/1

Manufacturer

Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-640

Product ID 68382-640_9e44a416-1d3d-418c-a113-f6c65175b564

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207769

Listing Expiration 2026-12-31

Marketing Start 2018-06-04

Pharmacologic Class

Established (EPC)

5-alpha reductase inhibitor [epc]

Mechanism of Action

5-alpha reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382640

Hyphenated Format 68382-640

Supplemental Identifiers

RxCUI

996097

UNII

O0J6XJN02I 11SV1951MR

NUI

N0000175836 N0000000126

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dutasteride and tamsulosin hydrochloride (source: ndc)

Generic Name dutasteride and tamsulosin hydrochloride (source: ndc)

Application Number ANDA207769 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

.5 mg/1
.4 mg/1

source: ndc

Packaging

30 CAPSULE in 1 BOTTLE (68382-640-06)
90 CAPSULE in 1 BOTTLE (68382-640-16)

source: ndc

Packages (2)

68382-640-06 30 CAPSULE in 1 BOTTLE (68382-640-06) 68382-640-16 90 CAPSULE in 1 BOTTLE (68382-640-16)

Ingredients (2)

dutasteride (.5 mg/1) tamsulosin hydrochloride (.4 mg/1)

Linked Drug Pages (1)

Dutasteride and tamsulosin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "9e44a416-1d3d-418c-a113-f6c65175b564", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["O0J6XJN02I", "11SV1951MR"], "rxcui": ["996097"], "spl_set_id": ["d6557691-7910-4006-9268-410583e437d1"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68382-640-06)", "package_ndc": "68382-640-06", "marketing_start_date": "20180604"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68382-640-16)", "package_ndc": "68382-640-16", "marketing_start_date": "20180604"}], "brand_name": "Dutasteride and tamsulosin hydrochloride", "product_id": "68382-640_9e44a416-1d3d-418c-a113-f6c65175b564", "dosage_form": "CAPSULE", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]", "Adrenergic alpha-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]"], "product_ndc": "68382-640", "generic_name": "Dutasteride and tamsulosin hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dutasteride and tamsulosin hydrochloride", "active_ingredients": [{"name": "DUTASTERIDE", "strength": ".5 mg/1"}, {"name": "TAMSULOSIN HYDROCHLORIDE", "strength": ".4 mg/1"}], "application_number": "ANDA207769", "marketing_category": "ANDA", "marketing_start_date": "20180604", "listing_expiration_date": "20261231"}