Nystatin

Product NDC
63629-2516
11-digit product format
636292516
Labeler code
63629
Product ID
63629-2516_76c4c131-29b4-4e9a-af1b-ca97c467e221
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA207767
Marketing category
ANDA
Marketing start
2020-06-24
Substance
NYSTATIN
Active strength
100000 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
63629-2516-16362925160115 g in 1 TUBE (63629-2516-1) 15 g2021-05-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nystatin Ointment, USPBryant Ranch Prepack2023-03-03HUMAN PRESCRIPTION DRUG LABEL102