NYSTATIN - nystatin ointment 
Zydus Lifesciences Limited

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Nystatin Ointment USP
For Topical Use Only
Not for Ophthalmic Use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1357-1

Nystatin Ointment USP, 15 g

Rx only

Carton 15 g
NYSTATIN 
nystatin ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1357
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN100000 U  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorYELLOW (YELLOW) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1357-115 g in 1 TUBE; Type 0: Not a Combination Product08/08/2018
2NDC:70771-1357-230 g in 1 TUBE; Type 0: Not a Combination Product08/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776708/08/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650650802ANALYSIS(70771-1357) , MANUFACTURE(70771-1357)

Revised: 11/2022
Document Id: b425ab8b-fc3a-4183-972c-b93fe5014b27
Set id: 6aa2f67e-9636-45e5-be1b-83e7ab86e436
Version: 4
Effective Time: 20221105
 
Zydus Lifesciences Limited