NYSTATIN AND TRIAMCINOLONE ACETONIDE

Product NDC
61748-425
11-digit product format
617480425
Labeler code
61748
Product ID
61748-425_c83da649-ceb2-4cb7-9327-bdd40659a691
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin and triamcinolone acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Versapharm Incorporated
Application
ANDA207217
Marketing category
ANDA
Marketing start
2017-09-01
Marketing end
0000-00-00
Substance
NYSTATIN; TRIAMCINOLONE ACETONIDE
Active strength
100000 [USP'U]/g; mg/g
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61748-425-15617480425151 TUBE in 1 CARTON (61748-425-15) > 15 g in 1 TUBE1 tube2017-09-010000-00-00NoNoCurrent
61748-425-30617480425301 TUBE in 1 CARTON (61748-425-30) > 30 g in 1 TUBE1 tube2017-09-010000-00-00NoNoCurrent
61748-425-60617480425601 TUBE in 1 CARTON (61748-425-60) > 60 g in 1 TUBE1 tube2017-09-010000-00-00NoNoCurrent