FINASTERIDE - finasteride tablet, film coated 
Zydus Lifesciences Limited

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FINASTERIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1152-0 in bottle of 1000 tablets

Finasteride Tablets USP, 5 mg

Rx only

1000 tablets

Finasteride Tablets, 5 mg
FINASTERIDE 
finasteride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1152
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G) FINASTERIDE5 mg
Inactive Ingredients
Ingredient NameStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SHELLAC (UNII: 46N107B71O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Product Characteristics
ColorBLUE (blue) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code ZE;56
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1152-330 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
2NDC:70771-1152-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
3NDC:70771-1152-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
4NDC:70771-1152-410 in 1 CARTON12/05/2017
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07890012/05/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1152) , MANUFACTURE(70771-1152)

Revised: 10/2022
Document Id: 5068fb9d-4d3e-4ebc-ac25-5a42a89a5efc
Set id: 16c0be08-b6af-4cb1-b20f-9934c9f78d32
Version: 4
Effective Time: 20221013
 
Zydus Lifesciences Limited