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Minoxidil

Minoxidil Tablets USP Revised: June 2009 Rx only 190799

Approved
Approval ID

9a290e8e-730a-4160-a367-c003bc04a2aa

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 26, 2010

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

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 Code68151-2032
Application NumberANDA071345
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minoxidil
Product Specifications
Route of AdministrationORAL
Effective DateJuly 26, 2010
FDA Product Classification

INGREDIENTS (7)

MINOXIDILActive
Quantity: 10 mg in 1 1
Code: 5965120SH1
Classification: ACTIB
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

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Minoxidil - FDA Drug Approval Details