Nystatin and Triamcinolone Acetonide

Product NDC
64380-836
11-digit product format
643800836
Labeler code
64380
Product ID
64380-836_99342793-1dda-45c5-9a39-b9e5ae8137ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin and Triamcinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Strides Pharma Science Limited
Application
ANDA210077
Marketing category
ANDA
Marketing start
2019-05-15
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-836-22GM - Gram64380-83607ce501c-d1a6-45e5-a42d-29eb70a3cfb912019-05-02
64380-836-23GM - Gram64380-83615b94d75-872c-40fd-bc82-73663348104e12019-05-02
64380-836-53GM - Gram64380-836645693d4-ff31-4060-b84d-54b7dc64ad1c12019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-836-22643800836221 TUBE in 1 CARTON (64380-836-22) > 15 g in 1 TUBE1 tube2019-05-150000-00-00NoNoCurrent
64380-836-23643800836231 TUBE in 1 CARTON (64380-836-23) > 30 g in 1 TUBE1 tube2019-05-150000-00-00NoNoCurrent
64380-836-53643800836531 TUBE in 1 CARTON (64380-836-53) > 60 g in 1 TUBE1 tube2019-08-150000-00-00NoNoCurrent