Salsalate
SALSALATE TABLETS, USP 500 MG AND 750 MG
Approved
Approval ID
52021032-7ab6-48e0-b290-994bae0e44cc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Salsalate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71205-983
Product Classification
G
Generic Name
Salsalate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2022
FDA Product Classification
INGREDIENTS (5)
SALSALATEActive
Quantity: 750 mg in 1 1
Code: V9MO595C9I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYVINYL ALCOHOL (100000 MW)Inactive
Code: 949E52Z6MY
Classification: IACT
Salsalate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71205-982
Product Classification
G
Generic Name
Salsalate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2022
FDA Product Classification
INGREDIENTS (6)
SALSALATEActive
Quantity: 500 mg in 1 1
Code: V9MO595C9I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYVINYL ALCOHOL (100000 MW)Inactive
Code: 949E52Z6MY
Classification: IACT