NYSTATIN: Package Insert and Label Information

NYSTATIN — nystatin powder
Cadila Healthcare Limited

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
(click image for full-size original)

NDC 70771-1585-2

Nystatin Topical Powder, USP

FOR TOPICAL USE ONLY

100,000 units per gram

Rx Only

30 GRAMS

30 gm label
(click image for full-size original)

NDC 70771-1585-3

Nystatin Topical Powder, USP

FOR TOPICAL USE ONLY

100,000 units per gram

Rx Only

60 GRAMS

60 gm label
(click image for full-size original)
NYSTATIN
nystatin powder
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1585
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NYSTATIN (NYSTATIN) NYSTATIN 100000 [USP’U] in 1 g
Inactive Ingredients
Ingredient Name Strength
TALC
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1585-1 15 g in 1 BOTTLE, PLASTIC None
2 NDC:70771-1585-3 60 g in 1 BOTTLE, PLASTIC None
3 NDC:70771-1585-2 30 g in 1 BOTTLE, PLASTIC None
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 Operations
CADILA HEALTHCARE LIMITED 677605858 ANALYSIS (70771-1585), MANUFACTURE (70771-1585)

Revised: 10/2021 Cadila Healthcare Limited

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