NYSTATIN

Product NDC
63629-8520
11-digit product format
636298520
Labeler code
63629
Product ID
63629-8520_e505ff47-c84a-4e72-a249-5232d13f216d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA062832
Marketing category
ANDA
Marketing start
2020-08-14
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
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
63629-8520-163629852001473 mL in 1 BOTTLE (63629-8520-1) 473 ml2021-05-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NYSTATIN ORAL SUSPENSION, USP (100,000 units per mL)Bryant Ranch Prepack2023-01-26HUMAN PRESCRIPTION DRUG LABEL103