SULINDAC
SULINDAC TABLETS USP
Approved
Approval ID
6db52fd3-172f-47ab-8aa6-4f3d031c6b25
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2021
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code71335-0413
Application NumberANDA072051
Product Classification
M
Marketing Category
C73584
G
Generic Name
sulindac
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2022
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