FDA.reportPublic FDA data

Nystatin

Product NDC
17856-0037
11-digit product format
178560037
Labeler code
17856
Product ID
17856-0037_57320d11-f384-428c-9b3e-e58adc8d919f
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
E
Listing certified through
2018-12-31
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 productproduct17856-0037IInactivated by FDA2026-07-31
excluded packagepackage17856-003717856-0037-1IInactivated 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
17856-0037-12020-01-31C16284748780-19d75b9d0-c5aa-f424-e053-dadaa90a57ceNYSTATIN ORAL SUSPENSION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0037-1Nystatin5 mL in 1 CUP, UNIT-DOSESUSPENSION51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0037NYSTATIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.]1Legacy NDC, 1 package rows20160904_19af50e2-0535-44f4-8b31-49e0bfe6a415.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN19af50e2-0535-44f4-8b31-49e0bfe6a4151
312055nystatin 100000 UNT/ML Oral SuspensionSCD19af50e2-0535-44f4-8b31-49e0bfe6a4151
312055nystatin 100,000 UNT/ML Oral SuspensionSY19af50e2-0535-44f4-8b31-49e0bfe6a4151
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY19af50e2-0535-44f4-8b31-49e0bfe6a4151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0037-1178560037015 mL in 1 CUP, UNIT-DOSE5 mlHistorical