minoxidil

Generic: minoxidil

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name minoxidil
Generic Name minoxidil
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

minoxidil 2.5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-342
Product ID 43353-342_adc9595c-1b82-45f5-a679-ecf843d8baf2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072708
Listing Expiration 2026-12-31
Marketing Start 2013-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353342
Hyphenated Format 43353-342

Supplemental Identifiers

RxCUI
197987
UNII
5965120SH1
NUI
N0000175379 N0000175564

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 ANDA072708 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 9000 TABLET in 1 BOTTLE (43353-342-09)
source: ndc

Packages (1)

43353-342-09 9000 TABLET in 1 BOTTLE (43353-342-09)

Ingredients (1)

minoxidil (2.5 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": "adc9595c-1b82-45f5-a679-ecf843d8baf2", "openfda": {"nui": ["N0000175379", "N0000175564"], "unii": ["5965120SH1"], "rxcui": ["197987"], "spl_set_id": ["0dada91c-fa1c-4da4-ac0d-e68b017c8604"], "pharm_class_pe": ["Arteriolar Vasodilation [PE]"], "pharm_class_epc": ["Arteriolar Vasodilator [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "9000 TABLET in 1 BOTTLE (43353-342-09)", "package_ndc": "43353-342-09", "marketing_start_date": "20170602"}], "brand_name": "MINOXIDIL", "product_id": "43353-342_adc9595c-1b82-45f5-a679-ecf843d8baf2", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "43353-342", "generic_name": "minoxidil", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MINOXIDIL", "active_ingredients": [{"name": "MINOXIDIL", "strength": "2.5 mg/1"}], "application_number": "ANDA072708", "marketing_category": "ANDA", "marketing_start_date": "20130801", "listing_expiration_date": "20261231"}