Sertraline hydrochloride tablet, film coated

Ingredients and appearance - Product information

Sertraline hydrochloride tablet, film coated- Sertraline hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 55289-291
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Sertraline hydrochloride ( UNII: UTI8907Y6X)( Sertraline - UNII: QUC7NX6WMB ) 50 mgin 1

Inactive Ingredients

Ingredient Name Code
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polyvinyl alcohol ( UNII: 532B59J990)
Povidone k30 ( UNII: U725QWY32X)
Talc ( UNII: 7SEV7J4R1U)
Ferric oxide yellow ( UNII: EX438O2MRT)

Product Characteristics

Color BLUE (light blue) Imprint Code 5;7;W
Score 2 Shape OVAL (biconvex)
Size 12 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077864 USA

Labeler - PD-Rx Pharmaceuticals, Inc.( 156893695)

Establishment

Name ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack( 55289-291)