Nystatin

Product NDC
53217-022
11-digit product format
532170022
Labeler code
53217
Product ID
53217-022_342bbf92-0160-4f92-b1ce-98cedd5fd6d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA062840
Marketing category
ANDA
Marketing start
2002-09-03
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
2019-12-31
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
53217-022-012020-01-31C16284748780-19d75b9d0-7651-f424-e053-dadaa90a57ceNYSTATIN OINTMENT USP (100,000 units/g)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-022-01Nystatin15 g in 1 TUBEOINTMENT151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-022-01GM - Gram53217-0221a090c45-fab6-48e7-8f24-d8f78c47c49f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN OINTMENT [AIDAREX PHARMACEUTICALS LLC]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN OINTMENT [AIDAREX PHARMACEUTICALS LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN OINTMENT [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-022NYSTATIN OINTMENT [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140214_aae5b1f0-f852-4b64-a5ef-6f8334ae2b4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884308nystatin 100,000 UNT/GM Topical OintmentPSNaae5b1f0-f852-4b64-a5ef-6f8334ae2b4d1
884308nystatin 100 UNT/MG Topical OintmentSCDaae5b1f0-f852-4b64-a5ef-6f8334ae2b4d1
884308nystatin 100,000 UNT/GM Topical OintmentSYaae5b1f0-f852-4b64-a5ef-6f8334ae2b4d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53217-022-015321700220115 g in 1 TUBE15 gHistorical