Nystatin

Product NDC
68071-3911
11-digit product format
680713911
Labeler code
68071
Product ID
68071-3911_42f2113b-4399-d2bb-e063-6394a90a7cb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA061966
Marketing category
ANDA
Marketing start
2015-04-01
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
Pharmacologic classes
Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
BDF1O1C72ENYSTATIN1400-61-9NYSTATIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3911-5680713911051 TUBE in 1 CARTON (68071-3911-5) / 15 g in 1 TUBE1 tube2025-11-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nystatin Cream - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2025-11-06HUMAN PRESCRIPTION DRUG LABEL1