SULINDAC
Sulindac Tablets USP, 150 mg and 200 mg Rx only
Approved
Approval ID
96c73bd2-4577-487d-a642-bd8f91e94c3a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 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.
SULINDAC
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-018
Application NumberANDA072710
Product Classification
M
Marketing Category
C73584
G
Generic Name
SULINDAC
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (5)
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SULINDACActive
Quantity: 150 mg in 1 1
Code: 184SNS8VUH
Classification: ACTIB
SULINDAC
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-011
Application NumberANDA072711
Product Classification
M
Marketing Category
C73584
G
Generic Name
SULINDAC
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (5)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SULINDACActive
Quantity: 200 mg in 1 1
Code: 184SNS8VUH
Classification: ACTIB