Nystatin and Triamcinolone Acetonide

Product NDC
64980-325
11-digit product format
649800325
Labeler code
64980
Product ID
64980-325_bdfb700f-8946-4551-aaf5-e6051c458333
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin and Triamcinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Rising Pharmaceuticals, Inc.
Application
ANDA206785
Marketing category
ANDA
Marketing start
2018-02-15
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-325-15GM - Gram64980-3252c9edaa0-a9f7-456c-b2be-71a283570d7912018-05-09
64980-325-30GM - Gram64980-3256d036096-2462-4ce4-9979-33a8b64c104412018-05-09
64980-325-60GM - Gram64980-325f543cbf9-8611-438e-aa66-a2d8902f336c12018-05-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-325-15649800325151 TUBE in 1 CARTON (64980-325-15) > 15 g in 1 TUBE1 tube2018-02-150000-00-00NoNoCurrent
64980-325-30649800325301 TUBE in 1 CARTON (64980-325-30) > 30 g in 1 TUBE1 tube2018-02-150000-00-00NoNoCurrent
64980-325-60649800325601 TUBE in 1 CARTON (64980-325-60) > 60 g in 1 TUBE1 tube2018-02-150000-00-00NoNoCurrent