Quinine Sulfate
These highlights do not include all the information needed to use QUININE SULFATE CAPSULES safely and effectively. See full prescribing information for QUININE SULFATE CAPSULES.QUININE SULFATE capsules, for oral use Initial U.S. Approval: 2005
Approved
Approval ID
e782283e-2608-4fd6-a8b2-6c30b9d5d3b0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2023
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Quinine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-3002
Application NumberANDA091661
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (11)
QUININE SULFATEActive
Quantity: 324 mg in 1 1
Code: KF7Z0E0Q2B
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT