Nystatin

Product NDC
66267-952
11-digit product format
662670952
Labeler code
66267
Product ID
66267-952_1fa7bc90-f394-592a-e063-6394a90acab9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA064022
Marketing category
ANDA
Marketing start
1993-01-28
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
66267-952-302024-08-14C16284748780-1f386c64a-0990-0266-e053-dadaa90a7c1aNystatin Cream USP, 100,000 units per gram
66267-952-302023-01-30C16284748780-1f386c64a-0990-0266-e053-dadaa90a7c1aNystatin Cream USP, 100,000 units per gram

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-952-30Nystatin30 g in 1 BOXCREAM304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-952-30GM - Gram66267-9520d42f4bb-7e40-4e23-bb81-f1a0a4668d0112017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-952NYSTATIN CREAM [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240816_57825c04-dcb5-b76d-e053-2991aa0a4c1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSN57825c04-dcb5-b76d-e053-2991aa0a4c1d4
543546nystatin 100000 UNT/ML Topical CreamSCD57825c04-dcb5-b76d-e053-2991aa0a4c1d4
543546nystatin 100,000 UNT/GM Topical CreamSY57825c04-dcb5-b76d-e053-2991aa0a4c1d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-952-306626709523030 g in 1 BOX (66267-952-30) 30 g2017-08-240000-00-00NoNoCurrent