SULINDAC
SULINDAC TABLETS USP
Approved
Approval ID
41c7882e-530a-4ac1-8de4-8d1e7b391467
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 28, 2023
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sulindac
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-7335
Application NumberANDA072051
Product Classification
M
Marketing Category
C73584
G
Generic Name
sulindac
Product Specifications
Route of AdministrationORAL
Effective DateJuly 28, 2023
FDA Product Classification
INGREDIENTS (4)
sulindacActive
Quantity: 200 mg in 1 1
Code: 184SNS8VUH
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
sulindac
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-7334
Application NumberANDA072050
Product Classification
M
Marketing Category
C73584
G
Generic Name
sulindac
Product Specifications
Route of AdministrationORAL
Effective DateJuly 28, 2023
FDA Product Classification
INGREDIENTS (3)
sulindacActive
Quantity: 150 mg in 1 1
Code: 184SNS8VUH
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT