Quinidine Sulfate
Quinidine Sulfate Tablets USP Revised: June 2009 Rx only 190782
Approved
Approval ID
02a34403-3cb9-4de7-8c40-9da281a8e5e1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 25, 2012
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Quinidine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68151-1991
Application NumberANDA083288
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinidine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2012
FDA Product Classification
INGREDIENTS (5)
QUINIDINE SULFATEActive
Quantity: 200 mg in 1 1
Code: J13S2394HE
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT