Nystatin

Product NDC
50090-5315
11-digit product format
500905315
Labeler code
50090
Product ID
50090-5315_7b3059b0-402b-4cea-88c4-5e7e787a34e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203621
Marketing category
ANDA
Marketing start
2020-07-17
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
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]/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
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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
50090-5315-0Nystatin60 mL in 1 BOTTLE, DROPPERSUSPENSION606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5315NYSTATIN SUSPENSION [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 1 package rows20231020_cc3516cd-985c-489f-b4a1-8477876c5a97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSNcc3516cd-985c-489f-b4a1-8477876c5a976
312055nystatin 100000 UNT/ML Oral SuspensionSCDcc3516cd-985c-489f-b4a1-8477876c5a976
312055nystatin 100,000 UNT/ML Oral SuspensionSYcc3516cd-985c-489f-b4a1-8477876c5a976
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYcc3516cd-985c-489f-b4a1-8477876c5a976

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5315-05009053150060 mL in 1 BOTTLE, DROPPER (50090-5315-0) 60 ml2020-10-290000-00-00NoNoCurrent