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berkley and jensen minoxidil

BJWC Minoxidil Drug Facts

Approved
Approval ID

6cfa4553-1d0a-41eb-9059-83b8fac6ddd0

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 29, 2025

Manufacturers
FDA

BJWC

DUNS: 159082692

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 Code68391-294
Application NumberANDA091344
Product Classification
M
Marketing Category
C73584
G
Generic Name
Minoxidil
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 29, 2025
FDA Product Classification

INGREDIENTS (12)

MINOXIDILActive
Quantity: 5 g in 100 g
Code: 5965120SH1
Classification: ACTIB
BUTANEInactive
Code: 6LV4FOR43R
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOBUTANEInactive
Code: BXR49TP611
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
PROPANEInactive
Code: T75W9911L6
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT

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berkley and jensen minoxidil - FDA Drug Approval Details