Quinidine Sulfate
Quinidine Sulfate Tablets, USP 200 mg and 300 mg
Approved
Approval ID
a10b6ded-4fe0-4059-bd77-c45acc3c876d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2019
Manufacturers
FDA
Eon Labs, Inc.
DUNS: 012656273
Products 2
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 Code0185-1047
Application NumberANDA088072
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinidine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2019
FDA Product Classification
INGREDIENTS (5)
QUINIDINE SULFATEActive
Quantity: 300 mg in 1 1
Code: J13S2394HE
Classification: ACTIB
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Quinidine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0185-4346
Application NumberANDA088072
Product Classification
M
Marketing Category
C73584
G
Generic Name
Quinidine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2019
FDA Product Classification
INGREDIENTS (5)
QUINIDINE SULFATEActive
Quantity: 200 mg in 1 1
Code: J13S2394HE
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT