Nystatin

Product NDC
60687-800
11-digit product format
606870800
Labeler code
60687
Product ID
60687-800_11ff6ced-6e23-9aa1-e063-6294a90a7c04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203621
Marketing category
ANDA
Marketing start
2024-02-26
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
60687-800-176068708001710 TRAY in 1 CASE (60687-800-17) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-800-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-800-40) 10 tray2024-02-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nystatin Oral Suspension USP [100,000 units per mL] I0868C0124 R01/24American Health Packaging2024-02-22HUMAN PRESCRIPTION DRUG LABEL1