Nystatin

Product NDC
50090-3799
11-digit product format
500903799
Labeler code
50090
Product ID
50090-3799_f3cbc0e5-76a5-4dcd-91b3-4e1275c11c51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3799-02023-01-30C16284748780-1f386c64a-0397-0266-e053-dadaa90a7c1a98bd8ccb-0c68-47b9-bcb4-c5d8217868d9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3799-0Nystatin1 in 1 CARTONCREAM11
50090-3799-0Nystatin15 g in 1 TUBECREAM151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3799NYSTATIN (NYSTATIN) CREAM [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20190103_98bd8ccb-0c68-47b9-bcb4-c5d8217868d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSN98bd8ccb-0c68-47b9-bcb4-c5d8217868d91
543546nystatin 100000 UNT/ML Topical CreamSCD98bd8ccb-0c68-47b9-bcb4-c5d8217868d91
543546nystatin 100,000 UNT/GM Topical CreamSY98bd8ccb-0c68-47b9-bcb4-c5d8217868d91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3799-0500903799001 TUBE in 1 CARTON (50090-3799-0) > 15 g in 1 TUBE1 tube2018-11-080000-00-00NoNoCurrent