FDA.reportPublic FDA data

Nystatin Topical Powder

Product NDC
42806-185
11-digit product format
428060185
Labeler code
42806
Product ID
42806-185_8723c280-f501-46c5-8be5-8a3e9cbd28b9
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
Nystatin Topical Powder
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
42806-185-15Nystatin Topical Powder15 g in 1 BOTTLEPOWDER151
42806-185-30Nystatin Topical Powder30 g in 1 BOTTLEPOWDER301
42806-185-60Nystatin Topical Powder60 g in 1 BOTTLEPOWDER601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-185NYSTATIN TOPICAL POWDER POWDER [EPIC PHARMA, LLC]1Current NDC, 3 package rows20231221_fb2a480e-0bb1-445e-bbb6-701dea6dc631.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646456nystatin 100,000 UNT/GM Topical PowderPSNfb2a480e-0bb1-445e-bbb6-701dea6dc6311
646456nystatin 100 UNT/MG Topical PowderSCDfb2a480e-0bb1-445e-bbb6-701dea6dc6311
646456nystatin 100,000 UNT/GM Topical PowderSYfb2a480e-0bb1-445e-bbb6-701dea6dc6311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42806-185-154280601851515 g in 1 BOTTLE (42806-185-15) 15 g2023-04-14NoNoCurrent
42806-185-304280601853030 g in 1 BOTTLE (42806-185-30) 30 g2023-04-14NoNoCurrent
42806-185-604280601856060 g in 1 BOTTLE (42806-185-60) 60 g2023-04-14NoNoCurrent