MINOXIDIL
Minoxidil Tablets USP
Approved
Approval ID
02d7399f-94cc-f718-f214-587301edd138
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2023
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 2
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 Code42291-619
Application NumberANDA072709
Product Classification
M
Marketing Category
C73584
G
Generic Name
minoxidil
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MINOXIDILActive
Quantity: 10 mg in 1 1
Code: 5965120SH1
Classification: ACTIB
minoxidil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-618
Application NumberANDA072708
Product Classification
M
Marketing Category
C73584
G
Generic Name
minoxidil
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MINOXIDILActive
Quantity: 2.5 mg in 1 1
Code: 5965120SH1
Classification: ACTIB