dutasteride and tamsulosin hydrochloride (42291-031)

Drug Facts

Product Profile

Brand Name dutasteride and tamsulosin hydrochloride

Generic Name dutasteride and tamsulosin hydrochloride capsules

Labeler avkare

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

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

Manufacturer

AvKARE

Identifiers & Regulatory

Product NDC 42291-031

Product ID 42291-031_48483bec-9af4-f1bd-e063-6294a90a8d84

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202509

Listing Expiration 2027-12-31

Marketing Start 2023-11-15

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 42291031

Hyphenated Format 42291-031

Supplemental Identifiers

RxCUI

996097

UNII

O0J6XJN02I 11SV1951MR

NUI

N0000175836 N0000000126

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 capsules (source: ndc)

Application Number ANDA202509 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

.5 mg/1
.4 mg/1

source: ndc

Packaging

30 CAPSULE in 1 BOTTLE (42291-031-30)

source: ndc

Packages (1)

42291-031-30 30 CAPSULE in 1 BOTTLE (42291-031-30)

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": "48483bec-9af4-f1bd-e063-6294a90a8d84", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["O0J6XJN02I", "11SV1951MR"], "rxcui": ["996097"], "spl_set_id": ["0a334eb9-cacf-f213-e063-6394a90a46da"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (42291-031-30)", "package_ndc": "42291-031-30", "marketing_start_date": "20231115"}], "brand_name": "Dutasteride and Tamsulosin Hydrochloride", "product_id": "42291-031_48483bec-9af4-f1bd-e063-6294a90a8d84", "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": "42291-031", "generic_name": "Dutasteride and Tamsulosin Hydrochloride Capsules", "labeler_name": "AvKARE", "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": "ANDA202509", "marketing_category": "ANDA", "marketing_start_date": "20231115", "listing_expiration_date": "20271231"}