MedPath

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

SULINDAC - FDA Drug Approval Details