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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210532-001KLAYESTANYSTATIN100,000 UNITS/GMPOWDER / TOPICALAT2018-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A210532-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A210532-001KLAYESTA100,000 UNITS/GMPOWDER / TOPICALAT2018-04-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210532-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KLAYESTANYSTATIN TOPICAL POWDEREpic Pharma, LLC0df13b1e-0e07-4123-a83a-1d7afb56170f2025-12-17Adverse reactionsExact identifier
application applno (ANDA): 210532
application number: ANDA210532
Nystatin Topical PowderNYSTATIN TOPICAL POWDEREpic Pharma, LLCfb2a480e-0bb1-445e-bbb6-701dea6dc6312023-08-10Adverse reactionsExact identifier
application applno (ANDA): 210532
application number: ANDA210532
ndc (product): 42806-185
Nystatin Topical PowderNYSTATIN TOPICAL POWDEREpic Pharma, LLC7f313a3b-7a4c-47fb-ad9f-e267514db5272018-05-02Adverse reactionsExact identifier
application applno (ANDA): 210532
application number: ANDA210532

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BDF1O1C72EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
646456Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb2a480e-0bb1-445e-bbb6-701dea6dc631Available on FDA.report

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