TAMOXIFEN CITRATE- tamoxifen citrate tablet, film coated 
Zydus Lifesciences Limited

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Tamoxifen Citrate Tablets, USP

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1184-1 in bottle of 100 tablets

Tamoxifen Citrate Tablets USP, 10 mg

Rx Only

100 tablets

tamoxifen tablets

NDC 70771-1185-1 in bottle of 100 tablets

Tamoxifen Citrate Tablets USP, 20 mg

Rx Only

100 tablets

tamoxifen tablets
TAMOXIFEN CITRATE 
tamoxifen citrate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1184
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (TAMOXIFEN - UNII:094ZI81Y45) TAMOXIFEN10 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code 826
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1184-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
2NDC:70771-1184-990 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
3NDC:70771-1184-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
4NDC:70771-1184-8180 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20669401/03/2018
TAMOXIFEN CITRATE 
tamoxifen citrate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1185
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (TAMOXIFEN - UNII:094ZI81Y45) TAMOXIFEN20 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 827
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1185-330 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
2NDC:70771-1185-660 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
3NDC:70771-1185-990 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
4NDC:70771-1185-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
5NDC:70771-1185-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20669401/03/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1184, 70771-1185) , MANUFACTURE(70771-1184, 70771-1185)

Revised: 9/2023
Document Id: 4d48092a-f1fb-4bcd-b109-b48cffacfaec
Set id: 70052366-80f3-41bc-b2dd-c1efe9317243
Version: 6
Effective Time: 20230928
 
Zydus Lifesciences Limited