Nystatin

Product NDC
68071-2887
11-digit product format
680712887
Labeler code
68071
Product ID
68071-2887_ee16e538-95bc-e59f-e053-2a95a90afc10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA212557
Marketing category
ANDA
Marketing start
2019-07-24
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 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
68071-2887-32025-01-30C16284748780-12cef2736-7e1f-d83d-e063-dadaa90ab31fNystatin Cream USP, 100,000 units per gram FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2887-3Nystatin30 g in 1 TUBECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2887NYSTATIN CREAM [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20221124_ee16e52c-ebb0-3330-e053-2995a90af2e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSNee16e52c-ebb0-3330-e053-2995a90af2e81
543546nystatin 100000 UNT/ML Topical CreamSCDee16e52c-ebb0-3330-e053-2995a90af2e81
543546nystatin 100,000 UNT/GM Topical CreamSYee16e52c-ebb0-3330-e053-2995a90af2e81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2887-36807128870330 g in 1 TUBE (68071-2887-3) 30 g2022-11-220000-00-00NoNoCurrent