Nystatin

Product NDC
63629-2516
11-digit product format
636292516
Labeler code
63629
Product ID
63629-2516_76c4c131-29b4-4e9a-af1b-ca97c467e221
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bryant Ranch Prepack
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
63629-2516-1Nystatin15 g in 1 TUBEOINTMENT15102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2516-1GM - Gram63629-25168cab938e-290a-4d27-898d-79dbfb8af1b612021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2516NYSTATIN OINTMENT [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20230306_53d1c23b-9cf2-4941-8701-8a7da1b066cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884308nystatin 100,000 UNT/GM Topical OintmentPSN53d1c23b-9cf2-4941-8701-8a7da1b066cc102
884308nystatin 100 UNT/MG Topical OintmentSCD53d1c23b-9cf2-4941-8701-8a7da1b066cc102
884308nystatin 100,000 UNT/GM Topical OintmentSY53d1c23b-9cf2-4941-8701-8a7da1b066cc102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2516-16362925160115 g in 1 TUBE (63629-2516-1) 15 g2021-05-180000-00-00NoNoCurrent