Nystatin

Product NDC
63629-8695
11-digit product format
636298695
Labeler code
63629
Product ID
63629-8695_87837bc0-0c5a-4959-8b57-0bc7b93b729c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA062225
Marketing category
ANDA
Marketing start
2006-09-21
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
Rxcui543546

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
63629-8695-1Nystatin1 in 1 CARTONCREAM1107
63629-8695-1Nystatin30 g in 1 TUBECREAM30107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8695-1GM - Gram63629-86959c9049d3-ed3c-47a1-8758-1ce582c1776512021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8695NYSTATIN CREAM [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 2 package rows20240829_b69d9035-bdf5-4c5a-94d8-f8438f6f0567.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSNb69d9035-bdf5-4c5a-94d8-f8438f6f0567107
543546nystatin 100000 UNT/ML Topical CreamSCDb69d9035-bdf5-4c5a-94d8-f8438f6f0567107
543546nystatin 100,000 UNT/GM Topical CreamSYb69d9035-bdf5-4c5a-94d8-f8438f6f0567107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8695-1636298695011 TUBE in 1 CARTON (63629-8695-1) / 30 g in 1 TUBE1 tube2006-09-210000-00-00NoNoCurrent