Nystatin

Product NDC
50090-5221
11-digit product format
500905221
Labeler code
50090
Product ID
50090-5221_fd2b1b08-f183-4cef-b6e2-115279cfc3b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203621
Marketing category
ANDA
Marketing start
2016-02-01
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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
50090-5221-02023-01-30C16284748780-1f386c64a-3f8f-0266-e053-dadaa90a7c1aNystatin Oral Suspension USP [100,000 units per mL]

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5221-0Nystatin60 mL in 1 BOTTLE, DROPPERSUSPENSION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5221NYSTATIN SUSPENSION [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20201013_9233b813-01a2-4ce5-9a6d-26421882a727.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN9233b813-01a2-4ce5-9a6d-26421882a7271
312055nystatin 100000 UNT/ML Oral SuspensionSCD9233b813-01a2-4ce5-9a6d-26421882a7271
312055nystatin 100,000 UNT/ML Oral SuspensionSY9233b813-01a2-4ce5-9a6d-26421882a7271
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY9233b813-01a2-4ce5-9a6d-26421882a7271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5221-05009052210060 mL in 1 BOTTLE, DROPPER (50090-5221-0) 60 ml2020-10-070000-00-00NoNoCurrent