Mefloquine Hydrochloride
Mefloquine Hydrochloride Tablets, USP
Approved
Approval ID
43fde257-36ee-49ea-a03c-01a1a4e1da3d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2021
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
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 Code0054-0025
Application NumberANDA076523
Product Classification
M
Marketing Category
C73584
G
Generic Name
mefloquine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2021
FDA Product Classification
INGREDIENTS (11)
MEFLOQUINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 5Y9L3636O3
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CALCIUM ALGINATEInactive
Code: 8P20S56HZI
Classification: IACT
POLOXAMER 331Inactive
Code: IS93EQR73R
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT