Nystatin

Product NDC
63187-464
11-digit product format
631870464
Labeler code
63187
Product ID
63187-464_2aeb648a-b45f-4dd7-93f0-610d7490b464
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA062840
Marketing category
ANDA
Marketing start
2002-09-03
Substance
NYSTATIN
Active strength
100000 [USP'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 [USP'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
63187-464-15Nystatin15 g in 1 TUBEOINTMENT155
63187-464-15Nystatin1 in 1 CARTONOINTMENT15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN OINTMENT [PROFICIENT RX LP]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN OINTMENT [PROFICIENT RX LP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN OINTMENT [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-464NYSTATIN OINTMENT [PROFICIENT RX LP]5Current NDC, Legacy NDC, 2 package rows20221027_d7d04c02-d07d-4382-8f93-5c0c3e68790c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884308nystatin 100,000 UNT/GM Topical OintmentPSNd7d04c02-d07d-4382-8f93-5c0c3e68790c5
884308nystatin 100 UNT/MG Topical OintmentSCDd7d04c02-d07d-4382-8f93-5c0c3e68790c5
884308nystatin 100,000 UNT/GM Topical OintmentSYd7d04c02-d07d-4382-8f93-5c0c3e68790c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-464-15631870464151 TUBE in 1 CARTON (63187-464-15) / 15 g in 1 TUBE1 tube2019-01-010000-00-00NoNoCurrent