FDA.reportPublic FDA data

Nystatin Topical Powder

Product NDC
42806-178
11-digit product format
428060178
Labeler code
42806
Product ID
42806-178_eb386427-9b1d-4b13-9e18-0f9cc00b4cb7
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
2018-05-02
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
42806-178-15Nystatin Topical Powder15 g in 1 BOTTLEPOWDER153
42806-178-30Nystatin Topical Powder30 g in 1 BOTTLEPOWDER303
42806-178-60Nystatin Topical Powder60 g in 1 BOTTLEPOWDER603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-178-15GM - Gram42806-1789645ed68-b00f-40c3-b633-a0bedaccc81412018-11-06
42806-178-30GM - Gram42806-178db9b64df-c0b1-4cb0-8f21-6c402b05a4dd12018-11-06
42806-178-60GM - Gram42806-1788c4a0e64-b663-4716-91a0-6bbf7c650b1612018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-178NYSTATIN TOPICAL POWDER POWDER [EPIC PHARMA, LLC]3Current NDC, Legacy NDC, 3 package rows20180502_7f313a3b-7a4c-47fb-ad9f-e267514db527.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646456nystatin 100,000 UNT/GM Topical PowderPSN7f313a3b-7a4c-47fb-ad9f-e267514db5273
646456nystatin 100 UNT/MG Topical PowderSCD7f313a3b-7a4c-47fb-ad9f-e267514db5273
646456nystatin 100,000 UNT/GM Topical PowderSY7f313a3b-7a4c-47fb-ad9f-e267514db5273

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-178-154280601781515 g in 1 BOTTLE (42806-178-15) 15 g2018-05-020000-00-00NoNoCurrent
42806-178-304280601783030 g in 1 BOTTLE (42806-178-30) 30 g2018-05-020000-00-00NoNoCurrent
42806-178-604280601786060 g in 1 BOTTLE (42806-178-60) 60 g2018-05-020000-00-00NoNoCurrent