Nystatin

Product NDC
66267-953
11-digit product format
662670953
Labeler code
66267
Product ID
66267-953_1fa7bc90-f395-592a-e063-6394a90acab9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA062225
Marketing category
ANDA
Marketing start
2006-09-21
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
Pharmacologic classes
Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nystatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN100000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui543546

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
66267-953-152024-08-14C16284748780-1f386c64a-24eb-0266-e053-dadaa90a7c1aNYSTATIN CREAM USP DRUG FACTS
66267-953-152023-01-30C16284748780-1f386c64a-24eb-0266-e053-dadaa90a7c1aNYSTATIN CREAM USP DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-953-15Nystatin15 g in 1 BOXCREAM153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-953-15GM - Gram66267-9532d3e48c6-1861-4129-a67a-c5be2cdd8afd12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-953NYSTATIN CREAM [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240816_86cfb84c-dcd3-b229-e053-2a91aa0aed5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSN86cfb84c-dcd3-b229-e053-2a91aa0aed5c3
543546nystatin 100000 UNT/ML Topical CreamSCD86cfb84c-dcd3-b229-e053-2a91aa0aed5c3
543546nystatin 100,000 UNT/GM Topical CreamSY86cfb84c-dcd3-b229-e053-2a91aa0aed5c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-953-156626709531515 g in 1 BOX (66267-953-15) 15 g2019-04-180000-00-00NoNoCurrent