Salsalate tablet, film coated

Ingredients and appearance - Product information

Salsalate tablet, film coated- Salsalate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 64376-507
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Salsalate ( UNII: V9MO595C9I)( Salsalate - UNII: V9MO595C9I ) 500 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Hypromelloses ( UNII: 3NXW29V3WO)
Mineral oil ( UNII: T5L8T28FGP)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Stearic acid ( UNII: 4ELV7Z65AP)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color YELLOW Imprint Code BP;507
Score 1 Shape ROUND
Size 11 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
UNAPPROVED DRUG OTHER USA

Salsalate tablet, film coated- Salsalate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 64376-508
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Salsalate ( UNII: V9MO595C9I)( Salsalate - UNII: V9MO595C9I ) 750 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Hypromelloses ( UNII: 3NXW29V3WO)
Mineral oil ( UNII: T5L8T28FGP)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Stearic acid ( UNII: 4ELV7Z65AP)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color YELLOW Imprint Code BP;508
Score 2 Shape CAPSULE (capsule-shaped)
Size 19 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
UNAPPROVED DRUG OTHER USA

Labeler - Boca Pharmacal, LLC( 170266089)

Establishment

Name ID/FEI Business Operations
Boca Pharmacal, LLC 170266089 MANUFACTURE( 64376-507, 64376-508), PACK( 64376-507, 64376-508)