PHYTONADIONE - phytonadione tablet 
Zydus Lifesciences Limited

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Phytonadione Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Phytonadione Tablets USP, 5 mg

100 tablets

NDC 70771-1318-1

Rx only

label
PHYTONADIONE 
phytonadione tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1318
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857) PHYTONADIONE5 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorYELLOW (LIGHT YELLOW TO YELLOW) Score2 pieces
ShapeROUND (ROUND) Size7mm
FlavorImprint Code 1014
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1318-11 in 1 CARTON02/22/2019
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70771-1318-410 in 1 CARTON02/22/2019
2NDC:70771-1318-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:70771-1318-330 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21018902/22/2019
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (863362789)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1318) , MANUFACTURE(70771-1318)

Revised: 11/2022
Document Id: 40070531-4723-48f2-89b4-9efde4d1c71f
Set id: fa26f747-c64e-4090-a0cf-de3d3d9b004c
Version: 6
Effective Time: 20221101
 
Zydus Lifesciences Limited