FDA.reportPublic FDA data

Nystatin

Product NDC
33261-896
11-digit product format
332610896
Labeler code
33261
Product ID
33261-896_a7bdbe31-8699-40f4-b6a1-d30b99cb97ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA062838
Marketing category
ANDA
Marketing start
1988-12-22
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
500000 [USP'U]/1
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct33261-896IInactivated by FDA2026-07-31
excluded packagepackage33261-89633261-896-30IInactivated 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
A062838-001NYSTATINNYSTATIN500,000 UNITSTABLET / ORAL1988-12-22

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 22:54:322026-06A062838-001NYSTATIN500,000 UNITSTABLET / ORAL1988-12-22a50c72e98297…

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
33261-896-302020-01-31C16284748780-19d75b9d0-a261-f424-e053-dadaa90a57ceNYSTATIN TABLETS USP (oral)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-896-30Nystatin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-896-30EA - Each33261-89671785083-5ca0-4449-80d0-7037bda0b67f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PNYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TNYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-896NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140128_7e072c84-5639-424c-9b44-2358f6b9081b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312059nystatin 500,000 UNT Oral TabletPSN7e072c84-5639-424c-9b44-2358f6b9081b1
312059nystatin 500000 UNT Oral TabletSCD7e072c84-5639-424c-9b44-2358f6b9081b1
312059nystatin 500,000 UNT Oral TabletSY7e072c84-5639-424c-9b44-2358f6b9081b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-896-303326108963030 in 1 BOTTLE, PLASTICHistorical