Nystatin

Product NDC
62135-741
11-digit product format
621350741
Labeler code
62135
Product ID
62135-741_462a7357-7985-7f48-e063-6294a90ac5c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA062474
Marketing category
ANDA
Marketing start
2011-10-31
Substance
NYSTATIN
Active strength
500000 [USP'U]/1
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
NYSTATIN500000 [USP'U]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui312059

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
62135-741-90Nystatin90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-741-90EA - Each62135-74149248e91-f7df-438f-964b-df4d7c8e933a12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-741NYSTATIN TABLET, FILM COATED [CHARTWELL RX, LLC]2Current NDC, 1 package rows20241025_30175930-f5fa-403d-a3ac-3bdbbe723641.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312059nystatin 500,000 UNT Oral TabletPSN30175930-f5fa-403d-a3ac-3bdbbe7236413
312059nystatin 500000 UNT Oral TabletSCD30175930-f5fa-403d-a3ac-3bdbbe7236413
312059nystatin 500,000 UNT Oral TabletSY30175930-f5fa-403d-a3ac-3bdbbe7236413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-741-906213507419090 TABLET, FILM COATED in 1 BOTTLE (62135-741-90) 2023-08-08NoNoCurrent