Nystatin

Product NDC
68258-3046
11-digit product format
682583046
Labeler code
68258
Product ID
68258-3046_74567b8a-65a1-45be-8f6d-12261d9118ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA065315
Marketing category
ANDA
Marketing start
2006-05-31
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
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
68258-3046-32019-11-13C16284748780-197449f38-b79b-f6ea-e053-dbdaa90aa703NYSTATIN CREAM, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-3046-3Nystatin30 g in 1 TUBECREAM301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [DISPENSING SOLUTIONS, INC.]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [DISPENSING SOLUTIONS, INC.]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SNYSTATIN CREAM [DISPENSING SOLUTIONS, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN CREAM [DISPENSING SOLUTIONS, INC.]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9INYSTATIN CREAM [DISPENSING SOLUTIONS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BNYSTATIN CREAM [DISPENSING SOLUTIONS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RNYSTATIN CREAM [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNYSTATIN CREAM [DISPENSING SOLUTIONS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNYSTATIN CREAM [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-3046NYSTATIN CREAM [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20111013_377b0312-abfe-45eb-9e6e-ae348ec83325.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSN377b0312-abfe-45eb-9e6e-ae348ec833251
543546nystatin 100000 UNT/ML Topical CreamSCD377b0312-abfe-45eb-9e6e-ae348ec833251
543546nystatin 100,000 UNT/GM Topical CreamSY377b0312-abfe-45eb-9e6e-ae348ec833251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68258-3046-36825830460330 g in 1 TUBE30 gHistorical