FDA.reportPublic FDA data

Nystatin

Product NDC
42254-322
11-digit product format
422540322
Labeler code
42254
Product ID
42254-322_8ce02e76-303c-4e06-a47e-0a7bbf46c3f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA064042
Marketing category
ANDA
Marketing start
2012-01-27
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
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 productproduct42254-322IInactivated by FDA2026-07-31
excluded packagepackage42254-32242254-322-60IInactivated 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
A064042-001NYSTATINNYSTATIN100,000 UNITS/MLSUSPENSION / ORAL1994-02-28

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 22:54:322026-06A064042-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORAL1994-02-28a50c72e98297…

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-322-602019-09-24C16284748780-19350213a-3cc2-c013-e053-90daa90a1393Nystatin Oral Suspension, USP 100,000 units per mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-322-60Nystatin60 mL in 1 BOTTLE, DROPPERSUSPENSION601
42254-322-60Nystatin1 in 1 CARTONSUSPENSION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-322-60ML - Milliliter42254-322552f0046-9251-42f2-85df-72ca31d92f8412013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-322NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20130329_8ce02e76-303c-4e06-a47e-0a7bbf46c3f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN8ce02e76-303c-4e06-a47e-0a7bbf46c3f21
312055nystatin 100000 UNT/ML Oral SuspensionSCD8ce02e76-303c-4e06-a47e-0a7bbf46c3f21
312055nystatin 100,000 UNT/ML Oral SuspensionSY8ce02e76-303c-4e06-a47e-0a7bbf46c3f21
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY8ce02e76-303c-4e06-a47e-0a7bbf46c3f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42254-322-604225403226060 mL in 1 BOTTLE, DROPPER60 mlHistorical