leader minoxidil

Generic: minoxidil

Labeler: cardinal health 110, llc. dba leader
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leader minoxidil
Generic Name minoxidil
Labeler cardinal health 110, llc. dba leader
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

minoxidil 5 g/100mL

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0653
Product ID 70000-0653_cf5fb0e6-c973-4bd4-a03e-96822c7585a7
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075598
Listing Expiration 2026-12-31
Marketing Start 2024-03-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000653
Hyphenated Format 70000-0653

Supplemental Identifiers

RxCUI
311724
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 leader minoxidil (source: ndc)
Generic Name minoxidil (source: ndc)
Application Number ANDA075598 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 g/100mL
source: ndc
Packaging
  • 3 BOTTLE, DROPPER in 1 CARTON (70000-0653-1) / 60 mL in 1 BOTTLE, DROPPER
  • 60 mL in 1 BOTTLE, DROPPER (70000-0653-2)
source: ndc

Packages (2)

70000-0653-1 3 BOTTLE, DROPPER in 1 CARTON (70000-0653-1) / 60 mL in 1 BOTTLE, DROPPER 70000-0653-2 60 mL in 1 BOTTLE, DROPPER (70000-0653-2)

Ingredients (1)

minoxidil (5 g/100mL)

Linked Drug Pages (1)

Leader Minoxidil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "cf5fb0e6-c973-4bd4-a03e-96822c7585a7", "openfda": {"nui": ["N0000175379", "N0000175564"], "unii": ["5965120SH1"], "rxcui": ["311724"], "spl_set_id": ["fbb17735-6c1f-44d6-865b-feec83a66b69"], "pharm_class_pe": ["Arteriolar Vasodilation [PE]"], "pharm_class_epc": ["Arteriolar Vasodilator [EPC]"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE, DROPPER in 1 CARTON (70000-0653-1)  / 60 mL in 1 BOTTLE, DROPPER", "package_ndc": "70000-0653-1", "marketing_start_date": "20240304"}, {"sample": false, "description": "60 mL in 1 BOTTLE, DROPPER (70000-0653-2)", "package_ndc": "70000-0653-2", "marketing_start_date": "20240304"}], "brand_name": "Leader Minoxidil", "product_id": "70000-0653_cf5fb0e6-c973-4bd4-a03e-96822c7585a7", "dosage_form": "SOLUTION", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "70000-0653", "generic_name": "minoxidil", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Minoxidil", "active_ingredients": [{"name": "MINOXIDIL", "strength": "5 g/100mL"}], "application_number": "ANDA075598", "marketing_category": "ANDA", "marketing_start_date": "20240304", "listing_expiration_date": "20261231"}