NYSTATIN - nystatin powder 
Zydus Lifesciences Limited

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Nystatin Topical Powder, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1585-1

Nystatin Topical Powder, USP

FOR TOPICAL USE ONLY

100,000 units per gram

Rx Only

15 GRAMS

15 gm label

NDC 70771-1585-2

Nystatin Topical Powder, USP

FOR TOPICAL USE ONLY

100,000 units per gram

Rx Only

30 GRAMS

30 gm label

NDC 70771-1585-3

Nystatin Topical Powder, USP

FOR TOPICAL USE ONLY

100,000 units per gram

Rx Only

60 GRAMS

60 gm label
NYSTATIN 
nystatin powder
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1585
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN100000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1585-115 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/06/2021
2NDC:70771-1585-360 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/06/2021
3NDC:70771-1585-230 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/06/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20858110/06/2021
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited677605858ANALYSIS(70771-1585) , MANUFACTURE(70771-1585)

Revised: 10/2022
Document Id: 99c9fc84-8300-46fe-af6d-f4f9ca85de03
Set id: 5d593aa9-f2e4-4adf-9f02-37832ffcb5b4
Version: 3
Effective Time: 20221031
 
Zydus Lifesciences Limited