FDA.reportPublic FDA data

KLAYESTA

Product NDC
42806-186
11-digit product format
428060186
Labeler code
42806
Product ID
42806-186_d8220de7-25d0-46ba-b5a0-8f2f35bd5323
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin Topical Powder
Dosage form
POWDER
Route
TOPICAL
Labeler
Epic Pharma, LLC
Application
ANDA210532
Marketing category
ANDA
Marketing start
2023-04-14
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
KLAYESTA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN100000 U/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui646456

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
42806-186-15KLAYESTA15 g in 1 BOTTLEPOWDER153
42806-186-30KLAYESTA30 g in 1 BOTTLEPOWDER303
42806-186-60KLAYESTA60 g in 1 BOTTLEPOWDER603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-186-15GM - Gram42806-186974c91e4-e00e-4c3c-b389-1b931a11c01b12024-02-14
42806-186-30GM - Gram42806-186bf90ccff-027b-4288-8a48-485f9016184012024-02-14
42806-186-60GM - Gram42806-18616747d14-8641-4c41-bc45-e4fb8c9c990c12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-186KLAYESTA (NYSTATIN TOPICAL POWDER) POWDER [EPIC PHARMA, LLC]2Current NDC, 3 package rows20241222_0df13b1e-0e07-4123-a83a-1d7afb56170f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646456nystatin 100,000 UNT/GM Topical PowderPSN0df13b1e-0e07-4123-a83a-1d7afb56170f3
646456nystatin 100 UNT/MG Topical PowderSCD0df13b1e-0e07-4123-a83a-1d7afb56170f3
646456nystatin 100,000 UNT/GM Topical PowderSY0df13b1e-0e07-4123-a83a-1d7afb56170f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42806-186-154280601861515 g in 1 BOTTLE (42806-186-15) 15 g2023-04-14NoNoCurrent
42806-186-304280601863030 g in 1 BOTTLE (42806-186-30) 30 g2023-04-14NoNoCurrent
42806-186-604280601866060 g in 1 BOTTLE (42806-186-60) 60 g2023-04-14NoNoCurrent