SULINDAC
SULINDAC TABLETS USP
Approved
Approval ID
f4985b1b-7e2c-4911-897a-94c337794bab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
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 Code50090-2093
Application NumberANDA072051
Product Classification
M
Marketing Category
C73584
G
Generic Name
sulindac
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2021
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