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Minoxidil

Minoxidil

Approved
Approval ID

665cba3d-5f26-468a-a047-188a413fbede

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 30, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

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 Code72162-1490
Application NumberANDA071839
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minoxidil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MINOXIDILActive
Quantity: 10 mg in 1 1
Code: 5965120SH1
Classification: ACTIB

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 1/13/2017

DESCRIPTION

Minoxidil tablets contain minoxidil, an antihypertensive peripheral vasodilator. Minoxidil occurs as a white to off-white, odorless, crystalline solid that is soluble in water to the extent of approximately 2 mg/mL, is readily soluble in propylene glycol or ethanol, and is almost insoluble in acetone, chloroform or ethyl acetate. The chemical name for minoxidil is 2,4-pyrimidinediamine, 6-(1-piperidinyl)-, 3-oxide. The structural formula is represented at right:

this is the chemical structure

  • C 9H 15N 50 MW 209.25

Minoxidil tablets for oral administration contain either 2.5 mg or 10 mg of minoxidil. Inactive ingredients include colloidal silicon dioxide, corn starch, lactose anhydrous, magnesium stearate and microcrystalline cellulose.

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