Nystatin

Product NDC
55154-5788
11-digit product format
551545788
Labeler code
55154
Product ID
55154-5788_252d18b3-10dd-48e4-8cdf-f188c9c8e07d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Cardinal Health 107, LLC
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
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
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
55154-5788-5Nystatin5 in 1 BAGSUSPENSION57
55154-5788-5Nystatin5 mL in 1 CUP, UNIT-DOSESUSPENSION57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5788NYSTATIN SUSPENSION [CARDINAL HEALTH 107, LLC]5Current NDC, Legacy NDC, 2 package rows20240207_d59098da-1395-49fb-9fd6-947bbbeed56f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSNd59098da-1395-49fb-9fd6-947bbbeed56f7
312055nystatin 100000 UNT/ML Oral SuspensionSCDd59098da-1395-49fb-9fd6-947bbbeed56f7
312055nystatin 100,000 UNT/ML Oral SuspensionSYd59098da-1395-49fb-9fd6-947bbbeed56f7
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYd59098da-1395-49fb-9fd6-947bbbeed56f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-5788-5551545788055 CUP, UNIT-DOSE in 1 BAG (55154-5788-5) / 5 mL in 1 CUP, UNIT-DOSE2020-07-170000-00-00NoNoCurrent