Nystatin

Product NDC
68071-2483
11-digit product format
680712483
Labeler code
68071
Product ID
68071-2483_c80acf66-e967-414e-e053-2a95a90a8f3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA061966
Marketing category
ANDA
Marketing start
2015-04-01
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2483-32023-01-30C16284748780-1f386c64a-121f-0266-e053-dadaa90a7c1ac80acf66-e966-414e-e053-2a95a90a8f3a

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2483NYSTATIN (NYSTATIN CREAM) CREAM [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC20210727_c80acf66-e966-414e-e053-2a95a90a8f3a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2483-3680712483031 TUBE in 1 CARTON (68071-2483-3) > 30 g in 1 TUBE1 tube2021-07-260000-00-00NoNoCurrent