Mefloquine Hydrochloride
Mefloquine Hydrochloride TabletsRev. 07/11
Approved
Approval ID
b6ccbb82-3804-4f02-bf17-f07e22a8b02a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-561
Application NumberANDA077699
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mefloquine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 5, 2011
FDA Product Classification
INGREDIENTS (10)
MEFLOQUINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 5Y9L3636O3
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT