FDA.reportPublic FDA data

Nystatin

Product NDC
42254-067
11-digit product format
422540067
Labeler code
42254
Product ID
42254-067_ceb0fc2d-9039-4961-84b6-ceb2a2649c50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA062512
Marketing category
ANDA
Marketing start
1995-04-15
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 productproduct42254-067IInactivated by FDA2026-07-31
excluded packagepackage42254-06742254-067-60IInactivated 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
A062512-001NYSTATINNYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062512-001AA

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 22:54:322026-06A062512-001NYSTATIN100,000 UNITS/MLSUSPENSION / ORALAA1984-10-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062512-001AA1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nystatin Oral SuspensionNYSTATINXttrium Laboratories, Inc.4a670371-d373-1ba6-e063-6394a90a13b62026-02-06Adverse reactionsExact identifier
application applno (ANDA): 062512
application number: ANDA062512
NystatinNYSTATINA-S Medication Solutionse069d495-7f1a-4970-8f4d-aa93d124b3fc2023-02-04Adverse reactionsExact identifier
application applno (ANDA): 062512
application number: ANDA062512

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
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
42254-067-602019-09-24C16284748780-19350213a-3d97-c013-e053-90daa90a1393NYSTATIN ORAL SUSPENSION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-067-60Nystatin60 mL in 1 BOTTLE, GLASSSUSPENSION601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-067-60ML - Milliliter42254-067255b6506-edf6-4d6a-9e48-5904956f603b12012-07-24

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
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOANYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
potassium phosphate, dibasicINACTIVE INGREDIENTCI71S98N1ZNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN 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
42254-067NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120411_ceb0fc2d-9039-4961-84b6-ceb2a2649c50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSNceb0fc2d-9039-4961-84b6-ceb2a2649c501
312055nystatin 100000 UNT/ML Oral SuspensionSCDceb0fc2d-9039-4961-84b6-ceb2a2649c501
312055nystatin 100,000 UNT/ML Oral SuspensionSYceb0fc2d-9039-4961-84b6-ceb2a2649c501
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYceb0fc2d-9039-4961-84b6-ceb2a2649c501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42254-067-604225400676060 mL in 1 BOTTLE, GLASS60 mlHistorical