Nystatin

Product NDC
53002-8220
11-digit product format
530028220
Labeler code
53002
Product ID
53002-8220_55187fff-7448-40e7-bbc0-a665f0017ed0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA062472
Marketing category
ANDA
Marketing start
2006-09-15
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-8220-1Nystatin15 g in 1 TUBEOINTMENT155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-8220NYSTATIN OINTMENT [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_0ee89f89-e90d-4706-9fa5-a61b5fde4470.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884308nystatin 100,000 UNT/GM Topical OintmentPSN0ee89f89-e90d-4706-9fa5-a61b5fde44705
884308nystatin 100 UNT/MG Topical OintmentSCD0ee89f89-e90d-4706-9fa5-a61b5fde44705
884308nystatin 100,000 UNT/GM Topical OintmentSY0ee89f89-e90d-4706-9fa5-a61b5fde44705

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-8220-15300282200115 g in 1 TUBE (53002-8220-1) 15 g2018-10-010000-00-00NoNoCurrent