Salsalate
Salsalate Tablets, USP 500 mg and 750 mg Rx Only
Approved
Approval ID
cef8d6d6-a4e8-4502-8e2f-7cd5129a434c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 26, 2022
Manufacturers
FDA
ECI Pharmaceuticals LLC
DUNS: 962476029
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 Code51293-615
Product Classification
G
Generic Name
Salsalate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2022
FDA Product Classification
INGREDIENTS (9)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SALSALATEActive
Quantity: 500 mg in 1 1
Code: V9MO595C9I
Classification: ACTIB
Salsalate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51293-616
Product Classification
G
Generic Name
Salsalate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2022
FDA Product Classification
INGREDIENTS (9)
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SALSALATEActive
Quantity: 750 mg in 1 1
Code: V9MO595C9I
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT