Mefloquine Hydrochloride
Mefloquine Hydrochloride Tablets USP
Approved
Approval ID
7f0bb8c9-16b5-1d26-e053-2991aa0ad438
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-4702
Application NumberANDA076392
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mefloquine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2021
FDA Product Classification
INGREDIENTS (9)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MEFLOQUINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 5Y9L3636O3
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT