dutasteride

Generic: dutasteride

Labeler: marksans pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dutasteride
Generic Name dutasteride
Labeler marksans pharma limited
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dutasteride .5 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-011
Product ID 25000-011_85bb4dcb-29f9-4490-b88a-725183e258e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204376
Listing Expiration 2026-12-31
Marketing Start 2017-04-27

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 25000011
Hyphenated Format 25000-011

Supplemental Identifiers

RxCUI
351172
UNII
O0J6XJN02I
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 (source: ndc)
Generic Name dutasteride (source: ndc)
Application Number ANDA204376 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-03)
  • 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-07)
  • 4 BAG in 1 BOX (25000-011-27) / 2500 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (3)

25000-011-03 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-03) 25000-011-07 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-07) 25000-011-27 4 BAG in 1 BOX (25000-011-27) / 2500 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (1)

dutasteride (.5 mg/1)

Linked Drug Pages (1)

Dutasteride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "85bb4dcb-29f9-4490-b88a-725183e258e7", "openfda": {"nui": ["N0000175836", "N0000000126"], "unii": ["O0J6XJN02I"], "rxcui": ["351172"], "spl_set_id": ["c4bc56a1-e31c-44fb-bfb5-f77425ff1ea1"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-03)", "package_ndc": "25000-011-03", "marketing_start_date": "20170427"}, {"sample": false, "description": "90 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-07)", "package_ndc": "25000-011-07", "marketing_start_date": "20170427"}, {"sample": false, "description": "4 BAG in 1 BOX (25000-011-27)  / 2500 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "25000-011-27", "marketing_start_date": "20170427"}], "brand_name": "Dutasteride", "product_id": "25000-011_85bb4dcb-29f9-4490-b88a-725183e258e7", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "25000-011", "generic_name": "Dutasteride", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dutasteride", "active_ingredients": [{"name": "DUTASTERIDE", "strength": ".5 mg/1"}], "application_number": "ANDA204376", "marketing_category": "ANDA", "marketing_start_date": "20170427", "listing_expiration_date": "20261231"}