FDA.reportPublic FDA data

Nystatin

Product NDC
55154-1578
11-digit product format
551541578
Labeler code
55154
Product ID
55154-1578_0b2d8c88-351d-4f89-b113-96389498b376
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA062512
Marketing category
ANDA
Marketing start
2005-12-15
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
500000 [USP'U]/5mL
Pharmacologic classes
Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct55154-1578DDiscontinued by firm2026-07-31
excluded packagepackage55154-157855154-1578-5DDiscontinued 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-1578-5ML - Milliliter55154-15782a1bee5a-0c0f-48b7-86ec-c4fff8bb152b12020-01-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [CARDINAL HEALTH]1
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [CARDINAL HEALTH]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-1578-5551541578055 CUP, UNIT-DOSE in 1 BAG (55154-1578-5) > 5 mL in 1 CUP, UNIT-DOSE2005-12-150000-00-00NoNoCurrent