NYSTATIN

Product NDC
72189-278
11-digit product format
721890278
Labeler code
72189
Product ID
72189-278_2c290c08-d35f-21b4-e063-6394a90a73b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
CREAM
Route
ORAL; TOPICAL
Labeler
DIRECT RX
Application
ANDA064022
Marketing category
ANDA
Marketing start
2021-09-30
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-278-15NYSTATIN15 g in 1 BOXCREAM154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-278NYSTATIN CREAM [DIRECT RX]4Current NDC, Legacy NDC, 1 package rows20250121_cd387929-5b72-e3c0-e053-2a95a90adb22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSNcd387929-5b72-e3c0-e053-2a95a90adb224
543546nystatin 100000 UNT/ML Topical CreamSCDcd387929-5b72-e3c0-e053-2a95a90adb224
543546nystatin 100,000 UNT/GM Topical CreamSYcd387929-5b72-e3c0-e053-2a95a90adb224

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-278-157218902781515 g in 1 BOX (72189-278-15) 15 g2021-09-300000-00-00NoNoCurrent