FDA.reportPublic FDA data

Nystatin

Product NDC
50090-0245
11-digit product format
500900245
Labeler code
50090
Product ID
50090-0245_7506b8af-43b4-4cb7-8676-beaa7b11b1ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA065315
Marketing category
ANDA
Marketing start
2006-05-31
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
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 productproduct50090-0245DDiscontinued by firm2026-07-31
excluded packagepackage50090-024550090-0245-0DDiscontinued 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
A065315-001NYSTATINNYSTATIN100,000 UNITS/GMCREAM / TOPICAL2006-05-31

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 22:54:322026-06A065315-001NYSTATIN100,000 UNITS/GMCREAM / TOPICAL2006-05-31a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0245-0GM - Gram50090-0245796a9e60-d427-4461-a52f-551fc7a2310512018-08-13