FDA.reportPublic FDA data

Nystatin

Product NDC
17856-0538
11-digit product format
178560538
Labeler code
17856
Product ID
17856-0538_8a722d13-c10b-4cfd-b1cc-ae0cdb9e4236
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS 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
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17856-0538DDiscontinued by firm2026-07-31
excluded packagepackage17856-053817856-0538-1DDiscontinued by firm2026-07-31
excluded packagepackage17856-053817856-0538-5DDiscontinued by firm2026-07-31
excluded packagepackage17856-053817856-0538-6DDiscontinued by firm2026-07-31
excluded packagepackage17856-053817856-0538-7DDiscontinued by firm2026-07-31
excluded packagepackage17856-053817856-0538-8DDiscontinued by firm2026-07-31
excluded packagepackage17856-053817856-0538-9DDiscontinued by firm2026-07-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0538-12024-05-21C16284748780-19d75b9d0-9004-f424-e053-dadaa90a57ceNYSTATIN ORAL SUSPENSION, USP
17856-0538-52024-05-21C16284748780-19d75b9d0-9004-f424-e053-dadaa90a57ceNYSTATIN ORAL SUSPENSION, USP
17856-0538-62024-05-21C16284748780-19d75b9d0-9004-f424-e053-dadaa90a57ceNYSTATIN ORAL SUSPENSION, USP
17856-0538-72024-05-21C16284748780-19d75b9d0-9004-f424-e053-dadaa90a57ceNYSTATIN ORAL SUSPENSION, USP
17856-0538-82024-05-21C16284748780-19d75b9d0-9004-f424-e053-dadaa90a57ceNYSTATIN ORAL SUSPENSION, USP
17856-0538-92024-05-21C16284748780-19d75b9d0-9004-f424-e053-dadaa90a57ceNYSTATIN ORAL SUSPENSION, USP
17856-0538-12020-01-31C16284748780-19d75b9d0-9004-f424-e053-dadaa90a57ceNYSTATIN ORAL SUSPENSION, USP
17856-0538-52020-01-31C16284748780-19d75b9d0-9004-f424-e053-dadaa90a57ceNYSTATIN ORAL SUSPENSION, USP
17856-0538-62020-01-31C16284748780-19d75b9d0-9004-f424-e053-dadaa90a57ceNYSTATIN ORAL SUSPENSION, USP
17856-0538-72020-01-31C16284748780-19d75b9d0-9004-f424-e053-dadaa90a57ceNYSTATIN ORAL SUSPENSION, USP
17856-0538-82020-01-31C16284748780-19d75b9d0-9004-f424-e053-dadaa90a57ceNYSTATIN ORAL SUSPENSION, USP
17856-0538-92020-01-31C16284748780-19d75b9d0-9004-f424-e053-dadaa90a57ceNYSTATIN ORAL SUSPENSION, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0538NYSTATIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.]4Legacy NDC20240522_8d3531b9-13b4-471b-8315-9d05c80208f6.zip