Nystatin

Product NDC
80432-003
11-digit product format
804320003
Labeler code
80432
Product ID
80432-003_f1f0be1e-39c4-a6d4-e053-2a95a90af0b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin Oral Suspension
Dosage form
SUSPENSION
Route
ORAL
Labeler
TriRx Huntsville Pharmaceutical Services, LLC
Application
ANDA065148
Marketing category
ANDA
Marketing start
2019-09-01
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
Pharmacologic classes
Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80432-003-088043200030860 mL in 1 BOTTLE, DROPPER (80432-003-08) 60 ml2019-09-010000-00-00NoNoCurrent
80432-003-3380432000333473 mL in 1 BOTTLE, PLASTIC (80432-003-33) 473 ml2020-02-010000-00-00NoNoCurrent