regoxidine (for men)

Generic: minoxidil

Labeler: innovus pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name regoxidine (for men)
Generic Name minoxidil
Labeler innovus pharmaceuticals, inc.
Dosage Form AEROSOL, FOAM
Routes
TOPICAL
Active Ingredients

minoxidil 50 mg/g

Manufacturer
INNOVUS PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 57483-165
Product ID 57483-165_7f6c711d-2ee7-46d5-8b2c-4cf643bff18e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA218616
Listing Expiration 2027-12-31
Marketing Start 2025-05-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57483165
Hyphenated Format 57483-165

Supplemental Identifiers

RxCUI
645146 2264763
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 regoxidine (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 (57483-165-11) / 60 g in 1 CAN (57483-165-01)
  • 3 CAN in 1 CARTON (57483-165-13) / 60 g in 1 CAN (57483-165-01)
source: ndc

Packages (2)

57483-165-11 1 CAN in 1 CARTON (57483-165-11) / 60 g in 1 CAN (57483-165-01) 57483-165-13 3 CAN in 1 CARTON (57483-165-13) / 60 g in 1 CAN (57483-165-01)

Ingredients (1)

minoxidil (50 mg/g)

Linked Drug Pages (1)

REGOXIDINE (FOR MEN) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "7f6c711d-2ee7-46d5-8b2c-4cf643bff18e", "openfda": {"nui": ["N0000175379", "N0000175564"], "unii": ["5965120SH1"], "rxcui": ["645146", "2264763"], "spl_set_id": ["d191b3a9-0fb7-45cc-82a1-b64a79c0c125"], "pharm_class_pe": ["Arteriolar Vasodilation [PE]"], "pharm_class_epc": ["Arteriolar Vasodilator [EPC]"], "manufacturer_name": ["INNOVUS PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CAN in 1 CARTON (57483-165-11)  / 60 g in 1 CAN (57483-165-01)", "package_ndc": "57483-165-11", "marketing_start_date": "20251114"}, {"sample": false, "description": "3 CAN in 1 CARTON (57483-165-13)  / 60 g in 1 CAN (57483-165-01)", "package_ndc": "57483-165-13", "marketing_start_date": "20250503"}], "brand_name": "REGOXIDINE (FOR MEN)", "product_id": "57483-165_7f6c711d-2ee7-46d5-8b2c-4cf643bff18e", "dosage_form": "AEROSOL, FOAM", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "57483-165", "generic_name": "MINOXIDIL", "labeler_name": "INNOVUS PHARMACEUTICALS, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "REGOXIDINE (FOR MEN)", "active_ingredients": [{"name": "MINOXIDIL", "strength": "50 mg/g"}], "application_number": "ANDA218616", "marketing_category": "ANDA", "marketing_start_date": "20250503", "listing_expiration_date": "20271231"}