FDA.reportPublic FDA data

Nystatin

Product NDC
50090-3257
11-digit product format
500903257
Labeler code
50090
Product ID
50090-3257_bfee38b9-5f81-497d-ba4e-c34c24002614
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3257DDiscontinued by firm2026-07-31
excluded packagepackage50090-325750090-3257-0DDiscontinued 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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3257-0ML - Milliliter50090-3257731286f5-44dc-4951-b276-4f5274584d5712019-05-02