SERTRALINE HYDROCHLORIDE- sertraline hydrochloride tablet, film coated 
Cadila Healthcare Limited

----------

SERTRALINE HYDROCHLORIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-043-06 in bottles of 30 tablets

Sertraline Hydrochloride Tablets, 25 mg

30 Tablets

sertraline tablets 25 mg

NDC 65841-044-06 in bottles of 30 tablets

Sertraline Hydrochloride Tablets, 50 mg

30 Tablets

sertraline tablets 50 mg

NDC 65841-045-06 in bottles of 30 tablets

Sertraline Hydrochloride Tablets, 100 mg

30 Tablets

sertraline tablets 100 mg
SERTRALINE HYDROCHLORIDE 
sertraline hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-043
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB) SERTRALINE25 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorGREEN (LIGHT GREEN) Score2 pieces
ShapeROUND (ROUND) Size6mm
FlavorImprint Code Z;82
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-043-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
2NDC:65841-043-1850 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
3NDC:65841-043-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
4NDC:65841-043-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
5NDC:65841-043-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
6NDC:65841-043-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
7NDC:65841-043-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07710612/02/2017
SERTRALINE HYDROCHLORIDE 
sertraline hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-044
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB) SERTRALINE50 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorBLUE (LIGHT BLUE) Score2 pieces
ShapeROUND (ROUND) Size8mm
FlavorImprint Code Z;81
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-044-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
2NDC:65841-044-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
3NDC:65841-044-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
4NDC:65841-044-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
5NDC:65841-044-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
6NDC:65841-044-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07710612/02/2017
SERTRALINE HYDROCHLORIDE 
sertraline hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-045
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB) SERTRALINE100 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorYELLOW (YELLOW) Score2 pieces
ShapeROUND (ROUND) Size10mm
FlavorImprint Code Z;80
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-045-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
2NDC:65841-045-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
3NDC:65841-045-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
4NDC:65841-045-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
5NDC:65841-045-405000 in 1 BOTTLE; Type 0: Not a Combination Product12/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07710612/02/2017
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-043, 65841-044, 65841-045) , MANUFACTURE(65841-043, 65841-044, 65841-045)

Revised: 9/2020
Document Id: 7a75de5d-e255-4be3-92bf-e8f55eee07ef
Set id: 34c3d223-99bb-407d-abd4-7634f104e1f2
Version: 4
Effective Time: 20200914
 
Cadila Healthcare Limited