Nystatin and Triamcinolone Acetonide

Product NDC
68382-332
11-digit product format
683820332
Labeler code
68382
Product ID
68382-332_dada008c-5278-4a95-83b0-bba4f4999ac3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin and Triamcinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA207764
Marketing category
ANDA
Marketing start
2018-11-20
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
68382-332-01683820332011 TUBE in 1 CARTON (68382-332-01) > 15 g in 1 TUBE1 tube2018-11-200000-00-00NoNoCurrent
68382-332-02683820332021 TUBE in 1 CARTON (68382-332-02) > 30 g in 1 TUBE1 tube2018-11-200000-00-00NoNoCurrent
68382-332-03683820332031 TUBE in 1 CARTON (68382-332-03) > 60 g in 1 TUBE1 tube2018-11-200000-00-00NoNoCurrent