FDA.reportPublic FDA data

Nystatin

Product NDC
76519-1007
11-digit product format
765191007
Labeler code
76519
Product ID
76519-1007_4c109ffc-d99f-4beb-bc0a-4e340b56396c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
POWDER
Route
TOPICAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA065203
Marketing category
ANDA
Marketing start
2009-09-15
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76519-1007IInactivated by FDA2026-07-31
excluded packagepackage76519-100776519-1007-5IInactivated by FDA2026-07-31

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
A065203-001NYSTATINNYSTATIN100,000 UNITS/GMPOWDER / TOPICALATRS2004-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065203-001AT

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 22:54:322026-06A065203-001NYSTATIN100,000 UNITS/GMPOWDER / TOPICALATRS2004-07-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065203-001AT1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINDr. Reddy's Labratories Inc.6bde84a1-341d-09ce-58b6-f9a653dc98c52024-04-12Adverse reactionsExact identifier
application applno (ANDA): 065203
application number: ANDA065203

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76519-1007-52019-11-27C16284748780-19855d018-d970-cd31-e053-dbdaa90ab51aNYSTATIN TOPICAL POWDER, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1007-5Nystatin15 g in 1 BOTTLE, PLASTICPOWDER151

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN POWDER [H.J. HARKINS COMPANY, INC.]1
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN POWDER [H.J. HARKINS COMPANY, INC.]1
TalcINACTIVE INGREDIENT7SEV7J4R1UNYSTATIN POWDER [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1007NYSTATIN POWDER [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20121031_9e122c5f-65e4-4c92-aaa0-ae97dd725b1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646456nystatin 100,000 UNT/GM Topical PowderPSN9e122c5f-65e4-4c92-aaa0-ae97dd725b1a1
646456nystatin 100 UNT/MG Topical PowderSCD9e122c5f-65e4-4c92-aaa0-ae97dd725b1a1
646456nystatin 100,000 UNT/GM Topical PowderSY9e122c5f-65e4-4c92-aaa0-ae97dd725b1a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
76519-1007-57651910070515 g in 1 BOTTLE, PLASTIC15 gHistorical