minoxidil 5% (for men)

Generic: minoxidil

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name minoxidil 5% (for men)
Generic Name minoxidil
Labeler aurohealth llc
Dosage Form AEROSOL, FOAM
Routes
TOPICAL
Active Ingredients

minoxidil 50 mg/g

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-608
Product ID 58602-608_84225922-895c-4386-b8ef-9b0beb2d1b07
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA218616
Listing Expiration 2027-12-31
Marketing Start 2024-04-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602608
Hyphenated Format 58602-608

Supplemental Identifiers

RxCUI
645146
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 5% (for men) (source: ndc)
Generic Name minoxidil (source: ndc)
Application Number ANDA218616 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 1 CAN in 1 CARTON (58602-608-01) / 60 g in 1 CAN
  • 2 CAN in 1 CARTON (58602-608-02) / 60 g in 1 CAN
  • 3 CAN in 1 CARTON (58602-608-03) / 60 g in 1 CAN
  • 4 CAN in 1 CARTON (58602-608-04) / 60 g in 1 CAN
  • 6 CAN in 1 CARTON (58602-608-05) / 60 g in 1 CAN
source: ndc

Packages (5)

58602-608-01 1 CAN in 1 CARTON (58602-608-01) / 60 g in 1 CAN 58602-608-02 2 CAN in 1 CARTON (58602-608-02) / 60 g in 1 CAN 58602-608-03 3 CAN in 1 CARTON (58602-608-03) / 60 g in 1 CAN 58602-608-04 4 CAN in 1 CARTON (58602-608-04) / 60 g in 1 CAN 58602-608-05 6 CAN in 1 CARTON (58602-608-05) / 60 g in 1 CAN

Ingredients (1)

minoxidil (50 mg/g)

Linked Drug Pages (1)

MINOXIDIL 5% (FOR MEN) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "84225922-895c-4386-b8ef-9b0beb2d1b07", "openfda": {"nui": ["N0000175379", "N0000175564"], "unii": ["5965120SH1"], "rxcui": ["645146"], "spl_set_id": ["e6b3b997-cde9-476d-b08c-4d1010456d8b"], "pharm_class_pe": ["Arteriolar Vasodilation [PE]"], "pharm_class_epc": ["Arteriolar Vasodilator [EPC]"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CAN in 1 CARTON (58602-608-01)  / 60 g in 1 CAN", "package_ndc": "58602-608-01", "marketing_start_date": "20240422"}, {"sample": false, "description": "2 CAN in 1 CARTON (58602-608-02)  / 60 g in 1 CAN", "package_ndc": "58602-608-02", "marketing_start_date": "20240422"}, {"sample": false, "description": "3 CAN in 1 CARTON (58602-608-03)  / 60 g in 1 CAN", "package_ndc": "58602-608-03", "marketing_start_date": "20240422"}, {"sample": false, "description": "4 CAN in 1 CARTON (58602-608-04)  / 60 g in 1 CAN", "package_ndc": "58602-608-04", "marketing_start_date": "20240422"}, {"sample": false, "description": "6 CAN in 1 CARTON (58602-608-05)  / 60 g in 1 CAN", "package_ndc": "58602-608-05", "marketing_start_date": "20240422"}], "brand_name": "MINOXIDIL 5% (FOR MEN)", "product_id": "58602-608_84225922-895c-4386-b8ef-9b0beb2d1b07", "dosage_form": "AEROSOL, FOAM", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "58602-608", "generic_name": "MINOXIDIL", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MINOXIDIL 5% (FOR MEN)", "active_ingredients": [{"name": "MINOXIDIL", "strength": "50 mg/g"}], "application_number": "ANDA218616", "marketing_category": "ANDA", "marketing_start_date": "20240422", "listing_expiration_date": "20271231"}