NYSTATIN

Product NDC
64950-372
11-digit product format
649500372
Labeler code
64950
Product ID
64950-372_319a98e0-8009-47c9-9f40-9cd288c26e48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Genus Lifesciences Inc.
Application
ANDA065148
Marketing category
ANDA
Marketing start
2026-03-24
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
Pharmacologic classes
Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NYSTATIN
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui312055

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
64950-372-06NYSTATIN60 mL in 1 BOTTLE, DROPPERSUSPENSION602
64950-372-47NYSTATIN473 mL in 1 BOTTLESUSPENSION4732

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSNb25cbae5-eaf5-4501-b013-02c778ca4a4e2
312055nystatin 100000 UNT/ML Oral SuspensionSCDb25cbae5-eaf5-4501-b013-02c778ca4a4e2
312055nystatin 100,000 UNT/ML Oral SuspensionSYb25cbae5-eaf5-4501-b013-02c778ca4a4e2
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYb25cbae5-eaf5-4501-b013-02c778ca4a4e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64950-372-066495003720660 mL in 1 BOTTLE, DROPPER (64950-372-06) 60 ml2026-05-11NoNoCurrent
64950-372-4764950037247473 mL in 1 BOTTLE (64950-372-47) 473 ml2026-03-24NoNoCurrent