Nystatin and Triamcinolone Acetonide

Product NDC
63629-2497
11-digit product format
636292497
Labeler code
63629
Product ID
63629-2497_dbe7b437-6b8e-44e5-b7d5-aa3f96c50d4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin and Triamcinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA207741
Marketing category
ANDA
Marketing start
2019-09-28
Substance
NYSTATIN; TRIAMCINOLONE ACETONIDE
Active strength
100000; 1 [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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
BDF1O1C72ENYSTATIN1400-61-9NYSTATIN
F446C597KATRIAMCINOLONE ACETONIDE76-25-5TRIAMCINOLONE ACETONIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-2497-1636292497011 TUBE in 1 CARTON (63629-2497-1) / 15 g in 1 TUBE1 tube2019-09-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nystatin and Triamcinolone AcetonideBryant Ranch Prepack2024-03-14HUMAN PRESCRIPTION DRUG LABEL1089