Nystatin and Triamcinolone Acetonide

Product NDC
71589-016
11-digit product format
715890016
Labeler code
71589
Product ID
71589-016_1331f4e0-cf13-4a6b-9a18-587ebd6ee4ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin and Triamcinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aleor Dermaceuticals Limited
Application
ANDA214186
Marketing category
ANDA
Marketing start
2022-03-15
Marketing end
0000-00-00
Substance
NYSTATIN; TRIAMCINOLONE ACETONIDE
Active strength
100000 [USP'U]/g; mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71589-016-15715890016151 TUBE in 1 CARTON (71589-016-15) > 15 g in 1 TUBE1 tube2022-03-150000-00-00NoNoCurrent
71589-016-30715890016301 TUBE in 1 CARTON (71589-016-30) > 30 g in 1 TUBE1 tube2022-03-150000-00-00NoNoCurrent
71589-016-60715890016601 TUBE in 1 CARTON (71589-016-60) > 60 g in 1 TUBE1 tube2022-03-150000-00-00NoNoCurrent