Minoxidil
Minoxidil Spray
Approved
Approval ID
03738dd6-a42c-0986-e063-6294a90a1cc0
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Jan 30, 2025
Manufacturers
FDA
Roman Health Ventures Inc.
DUNS: 081317350
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Minoxidil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72484-097
Application NumberANDA076239
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minoxidil
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 30, 2025
FDA Product Classification
INGREDIENTS (4)
MINOXIDILActive
Quantity: 5 g in 100 mL
Code: 5965120SH1
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT