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Mefloquine Hydrochloride

Approved
Approval ID

1c47fd79-c0ca-42d6-9910-774272b25bc1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 12, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

mefloquine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-5434
Application NumberANDA076175
Product Classification
M
Marketing Category
C73584
G
Generic Name
mefloquine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2010
FDA Product Classification

INGREDIENTS (8)

MEFLOQUINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 5Y9L3636O3
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Mefloquine Hydrochloride - FDA Drug Approval Details