MedPath

Mefloquine Hydrochloride

Mefloquine Hydrochloride Tablets USP

Approved
Approval ID

9cbe26c7-7313-4cd6-9514-9190af1de763

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 4, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

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

NDC Product Code50090-2396
Application NumberANDA076392
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 31, 2016
Generic NameMefloquine Hydrochloride

INGREDIENTS (9)

MEFLOQUINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 5Y9L3636O3
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Mefloquine Hydrochloride - FDA Drug Approval Details