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: 24236-739
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 glycol ( 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

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 24236-739-38 3 in 1 BLISTER PACK 2012/05/10

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077864 USA 2012/05/10

Labeler - REMEDYREPACK INC.( 829572556)

Principal display panel

DRUG: Sertraline Hydrochloride

GENERIC: sertraline hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 24236-739-38

COLOR: blue

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 12 mm

IMPRINT: 5;7;W

PACKAGING: 3 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • SERTRALINE HYDROCHLORIDE 50mg in 1

INACTIVE INGREDIENT(S):

  • FD&C BLUE NO. 2
  • POLYVINYL ALCOHOL
  • POVIDONE K30
  • TALC
  • TITANIUM DIOXIDE
  • CELLULOSE, MICROCRYSTALLINE
  • MAGNESIUM STEARATE
  • FERRIC OXIDE YELLOW
  • POLYETHYLENE GLYCOL
  • SODIUM STARCH GLYCOLATE TYPE A POTATO