NYSTATIN

Product NDC
68071-2621
11-digit product format
680712621
Labeler code
68071
Product ID
68071-2621_d5f4c2e1-4831-3aae-e053-2995a90aba47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
POWDER
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA208581
Marketing category
ANDA
Marketing start
2021-10-06
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
2023-12-31
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
68071-2621-62025-01-30C16284748780-12cef2736-5cb9-d83d-e063-dadaa90ab31fNYSTATIN TOPICAL POWDER, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2621-6NYSTATIN60 g in 1 BOTTLE, PLASTICPOWDER601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2621NYSTATIN POWDER [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220120_d5f4c2d8-a637-4396-e053-2995a90a600f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646456nystatin 100,000 UNT/GM Topical PowderPSNd5f4c2d8-a637-4396-e053-2995a90a600f1
646456nystatin 100 UNT/MG Topical PowderSCDd5f4c2d8-a637-4396-e053-2995a90a600f1
646456nystatin 100,000 UNT/GM Topical PowderSYd5f4c2d8-a637-4396-e053-2995a90a600f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2621-66807126210660 g in 1 BOTTLE, PLASTIC (68071-2621-6) 60 g2022-01-190000-00-00NoNoCurrent