SULINDAC
SULINDAC TABLETS USP
Approved
Approval ID
1fffe88d-50c8-45cf-ac7c-a62b665c89a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2024
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
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 Code72789-374
Application NumberANDA072051
Product Classification
M
Marketing Category
C73584
G
Generic Name
sulindac
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2024
FDA Product Classification
INGREDIENTS (4)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SULINDACActive
Quantity: 200 mg in 1 1
Code: 184SNS8VUH
Classification: ACTIB