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Minoxidil

Minoxidil Tablets USP Revised: March 2016 Rx Only

Approved
Approval ID

637718aa-a453-4acd-a992-590d637b63a3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 1, 2023

Manufacturers
FDA

Proficient Rx LP

DUNS: 079196022

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 Code71205-757
Application NumberANDA071344
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minoxidil
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2023
FDA Product Classification

INGREDIENTS (7)

MINOXIDILActive
Quantity: 2.5 mg in 1 1
Code: 5965120SH1
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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