FDA.reportPublic FDA data

Nystatin

Product NDC
42254-303
11-digit product format
422540303
Labeler code
42254
Product ID
42254-303_1211504c-f89b-42ed-9d7a-2e1a658a9ccf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
POWDER
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA065203
Marketing category
ANDA
Marketing start
2009-09-15
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
42254-303-152019-09-24C16284748780-19350213a-3d8e-c013-e053-90daa90a1393NYSTATIN TOPICAL POWDER, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-303-15Nystatin15 g in 1 BOTTLE, PLASTICPOWDER151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-303-15GM - Gram42254-303f2707c38-30ad-4bb7-bcce-0b8212fc0ce412013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN POWDER [REBEL DISTRIBUTORS CORP]1
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN POWDER [REBEL DISTRIBUTORS CORP]1
TalcINACTIVE INGREDIENT7SEV7J4R1UNYSTATIN POWDER [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-303NYSTATIN POWDER [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20130329_1211504c-f89b-42ed-9d7a-2e1a658a9ccf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646456nystatin 100,000 UNT/GM Topical PowderPSN1211504c-f89b-42ed-9d7a-2e1a658a9ccf1
646456nystatin 100 UNT/MG Topical PowderSCD1211504c-f89b-42ed-9d7a-2e1a658a9ccf1
646456nystatin 100,000 UNT/GM Topical PowderSY1211504c-f89b-42ed-9d7a-2e1a658a9ccf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42254-303-154225403031515 g in 1 BOTTLE, PLASTIC15 gHistorical