minoxidil

Generic: minoxidil

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name minoxidil
Generic Name minoxidil
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

minoxidil 10 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 53489-387
Product ID 53489-387_4a668fcd-612e-6944-e063-6394a90a9e2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072709
Listing Expiration 2027-12-31
Marketing Start 1995-12-14

Pharmacologic Class

Established (EPC)
arteriolar vasodilator [epc]
Physiologic Effect
arteriolar vasodilation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53489387
Hyphenated Format 53489-387

Supplemental Identifiers

RxCUI
197986 197987
UNII
5965120SH1
NUI
N0000175379 N0000175564

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 minoxidil (source: ndc)
Generic Name minoxidil (source: ndc)
Application Number ANDA072709 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53489-387-01)
  • 250 TABLET in 1 BOTTLE (53489-387-03)
  • 500 TABLET in 1 BOTTLE (53489-387-05)
  • 1000 TABLET in 1 BOTTLE (53489-387-10)
source: ndc

Packages (4)

53489-387-01 100 TABLET in 1 BOTTLE (53489-387-01) 53489-387-03 250 TABLET in 1 BOTTLE (53489-387-03) 53489-387-05 500 TABLET in 1 BOTTLE (53489-387-05) 53489-387-10 1000 TABLET in 1 BOTTLE (53489-387-10)

Ingredients (1)

minoxidil (10 mg/1)

Linked Drug Pages (1)

MINOXIDIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a668fcd-612e-6944-e063-6394a90a9e2f", "openfda": {"nui": ["N0000175379", "N0000175564"], "unii": ["5965120SH1"], "rxcui": ["197986", "197987"], "spl_set_id": ["0354a7f5-5917-44dc-9963-411104008cb5"], "pharm_class_pe": ["Arteriolar Vasodilation [PE]"], "pharm_class_epc": ["Arteriolar Vasodilator [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53489-387-01)", "package_ndc": "53489-387-01", "marketing_start_date": "19951214"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (53489-387-03)", "package_ndc": "53489-387-03", "marketing_start_date": "19951214"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (53489-387-05)", "package_ndc": "53489-387-05", "marketing_start_date": "19951214"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (53489-387-10)", "package_ndc": "53489-387-10", "marketing_start_date": "19951214"}], "brand_name": "MINOXIDIL", "product_id": "53489-387_4a668fcd-612e-6944-e063-6394a90a9e2f", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "53489-387", "generic_name": "minoxidil", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MINOXIDIL", "active_ingredients": [{"name": "MINOXIDIL", "strength": "10 mg/1"}], "application_number": "ANDA072709", "marketing_category": "ANDA", "marketing_start_date": "19951214", "listing_expiration_date": "20271231"}