nystatin

Product NDC
68788-9247
11-digit product format
687889247
Labeler code
68788
Product ID
68788-9247_f5d79b2a-e2de-4c03-9287-6f99f5f78a7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA062129
Marketing category
ANDA
Marketing start
2014-11-13
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9247DDiscontinued by firm2026-07-31
excluded packagepackage68788-924768788-9247-1DDiscontinued by firm2026-07-31
excluded packagepackage68788-924768788-9247-3DDiscontinued 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
A062129-001NYSTATINNYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A062129-001AT

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 22:54:322026-06A062129-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALATApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A062129-001AT1a50c72e98297…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
nystatinACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
AlgeldrateINACTIVE INGREDIENT03J11K103CNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
EthylenediamineINACTIVE INGREDIENT60V9STC53FNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
PEG-8 StearateINACTIVE INGREDIENT2P9L47VI5ENYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4MNYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN CREAM [PREFERRED PHARMACEUTICALS, INC.]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN 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