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
NDC Product Code0054-0025
Application NumberANDA076523
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 14, 2021
Generic Namemefloquine hydrochloride
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