Nystatin

Product NDC
50090-5845
11-digit product format
500905845
Labeler code
50090
Product ID
50090-5845_b497547b-3c93-4ea2-bc0e-5f0b1397b831
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA207767
Marketing category
ANDA
Marketing start
2020-06-24
Substance
NYSTATIN
Active strength
100000 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 U/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui884308

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
50090-5845-0Nystatin15 g in 1 TUBEOINTMENT155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5845-0GM - Gram50090-5845ff3b7e0d-157a-46b7-a9a0-4effb081a3bd12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5845NYSTATIN OINTMENT [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 1 package rows20231125_6a3bb3da-adf9-46d2-a5ff-f796e7aae7a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884308nystatin 100,000 UNT/GM Topical OintmentPSN6a3bb3da-adf9-46d2-a5ff-f796e7aae7a15
884308nystatin 100 UNT/MG Topical OintmentSCD6a3bb3da-adf9-46d2-a5ff-f796e7aae7a15
884308nystatin 100,000 UNT/GM Topical OintmentSY6a3bb3da-adf9-46d2-a5ff-f796e7aae7a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5845-05009058450015 g in 1 TUBE (50090-5845-0) 15 g2021-11-040000-00-00NoNoCurrent