Nystatin

Product NDC
42291-651
11-digit product format
422910651
Labeler code
42291
Product ID
42291-651_3f165da9-403f-6f69-e063-6294a90a45bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA062506
Marketing category
ANDA
Marketing start
2014-01-20
Substance
NYSTATIN
Active strength
500000 [USP'U]/1
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
NYSTATIN500000 [USP'U]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui312059

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
42291-651-90Nystatin90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-651NYSTATIN TABLET, FILM COATED [AVKARE]6Current NDC, Legacy NDC, 1 package rows20240111_8fd35f97-5405-2160-ca0f-35034ecd5a92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312059nystatin 500,000 UNT Oral TabletPSN8fd35f97-5405-2160-ca0f-35034ecd5a927
312059nystatin 500000 UNT Oral TabletSCD8fd35f97-5405-2160-ca0f-35034ecd5a927
312059nystatin 500,000 UNT Oral TabletSY8fd35f97-5405-2160-ca0f-35034ecd5a927

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-651-904229106519090 TABLET, FILM COATED in 1 BOTTLE (42291-651-90) 2014-01-200000-00-00NoNoCurrent