Sulindac
Sulindac Tablets USP, 150 mg and 200 mgRx only
Approved
Approval ID
ddbbaada-f55a-4032-a24c-a8c493933a45
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2021
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 Code50090-4976
Application NumberANDA072711
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sulindac
Product Specifications
Route of AdministrationORAL
Effective DateApril 22, 2019
FDA Product Classification
INGREDIENTS (5)
SULINDACActive
Quantity: 200 mg in 1 1
Code: 184SNS8VUH
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT