FDA.reportPublic FDA data

Nystatin

Product NDC
68788-0178
11-digit product format
687880178
Labeler code
68788
Product ID
68788-0178_02f598cc-dbb5-4a96-8b3d-f2dded317fd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA065315
Marketing category
ANDA
Marketing start
2014-01-13
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
2020-12-31
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 productproduct68788-0178DDiscontinued by firm2026-07-31
excluded packagepackage68788-017868788-0178-1DDiscontinued 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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9INYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1