Nystatin

Product NDC
63187-422
11-digit product format
631870422
Labeler code
63187
Product ID
63187-422_cc949ee7-fc09-4b2f-a26d-bb6a435f75c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA062949
Marketing category
ANDA
Marketing start
2010-07-21
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [PROFICIENT RX LP]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [PROFICIENT RX LP]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0NYSTATIN CREAM [PROFICIENT RX LP]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SNYSTATIN CREAM [PROFICIENT RX LP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNYSTATIN CREAM [PROFICIENT RX LP]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NYSTATIN CREAM [PROFICIENT RX LP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN CREAM [PROFICIENT RX LP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN CREAM [PROFICIENT RX LP]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9INYSTATIN CREAM [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NYSTATIN CREAM [PROFICIENT RX LP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN CREAM [PROFICIENT RX LP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNYSTATIN CREAM [PROFICIENT RX LP]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BNYSTATIN CREAM [PROFICIENT RX LP]1
SORBITOLINACTIVE INGREDIENT506T60A25RNYSTATIN CREAM [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNYSTATIN CREAM [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RNYSTATIN CREAM [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-422NYSTATIN CREAM [PROFICIENT RX LP]3Legacy NDC20210115_b9d5a099-00ef-40b6-90a4-254f2be551d5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-422-15631870422151 TUBE in 1 CARTON (63187-422-15) > 15 g in 1 TUBE1 tube2019-01-010000-00-00NoNoCurrent