NYSTATIN by Cadila Healthcare Limited / CADILA HEALTHCARE LIMITED NYSTATIN powder

NYSTATIN by

Drug Labeling and Warnings

NYSTATIN by is a Prescription medication manufactured, distributed, or labeled by Cadila Healthcare Limited, CADILA HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

NDC: 70771-1585-2

Nystatin Topical Powder, USP

FOR TOPICAL USE ONLY

100,000 units per gram

Rx Only

30 GRAMS

NDC: 70771-1585-3

Nystatin Topical Powder, USP

FOR TOPICAL USE ONLY

100,000 units per gram

Rx Only

60 GRAMS

INGREDIENTS AND APPEARANCE

NYSTATIN 
nystatin powder

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1585
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E)	NYSTATIN	100000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1585-1	15 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/06/2021
2	NDC: 70771-1585-3	60 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/06/2021
3	NDC: 70771-1585-2	30 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/06/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208581	10/06/2021

Labeler - Cadila Healthcare Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
CADILA HEALTHCARE LIMITED		677605858	ANALYSIS(70771-1585) , MANUFACTURE(70771-1585)