Nystatin and Triamcinolone Acetonide

Product NDC
71085-009
11-digit product format
710850009
Labeler code
71085
Product ID
71085-009_b6eaa871-a050-4ee4-99d2-baefe246546f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin and Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
IPG PHARMACEUTICALS, INC.
Application
ANDA062364
Marketing category
ANDA
Marketing start
1987-12-22
Marketing end
0000-00-00
Substance
NYSTATIN; TRIAMCINOLONE ACETONIDE
Active strength
100000 mg/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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71085-009-302025-12-29C16284748780-13b156c62-30e3-fb37-e063-e6dba90a4e07Nystatin and Triamcinolone Acetonide Cream, USP
71085-009-302025-07-29C16284748780-13b156c62-30e3-fb37-e063-e6dba90a4e07Nystatin and Triamcinolone Acetonide Cream, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71085-009-30GM - Gram71085-0092db868e5-25e1-48ef-ab12-cb1e397a831d12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71085-009NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [IPG PHARMACEUTICALS, INC.]1Legacy NDC20170218_32d1d24f-c0a1-412f-b8a8-b54ea1684352.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71085-009-30710850009301 TUBE in 1 CARTON (71085-009-30) > 30 g in 1 TUBE1 tube2017-01-090000-00-00NoNoCurrent