QUINIDINE SULFATE
Quinidine Sulfate Tablets, USP
Approved
Approval ID
b0d6341b-d880-4f0b-8844-bc788c03004a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2023
Manufacturers
FDA
EPIC PHARMA, LLC
DUNS: 827915443
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
quinidine sulfate tablet
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-513
Application NumberANDA088072
Product Classification
M
Marketing Category
C73584
G
Generic Name
quinidine sulfate tablet
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2021
FDA Product Classification
INGREDIENTS (5)
QUINIDINE SULFATEActive
Quantity: 200 mg in 1 1
Code: J13S2394HE
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
quinidine sulfate tablet
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-512
Application NumberANDA088072
Product Classification
M
Marketing Category
C73584
G
Generic Name
quinidine sulfate tablet
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2021
FDA Product Classification
INGREDIENTS (5)
QUINIDINE SULFATEActive
Quantity: 300 mg in 1 1
Code: J13S2394HE
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT