Nystatin

Product NDC
0603-7818
11-digit product format
006037818
Labeler code
0603
Product ID
0603-7818_62d0f1fd-d016-4396-b31d-8262b8a6521d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Par Pharmaceutical
Application
ANDA065315
Marketing category
ANDA
Marketing start
2006-05-31
Marketing end
2021-07-31
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-7818-74GM - Gram0603-78189cd1d0ed-a433-46e3-82b3-9a21b50665ea12012-07-24
0603-7818-78GM - Gram0603-78184cac82a9-ec1e-42c6-8452-0d52b397d31912012-07-24

DailyMed Socrata Ingredients#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSN377b0312-abfe-45eb-9e6e-ae348ec833251
543546nystatin 100000 UNT/ML Topical CreamSCD377b0312-abfe-45eb-9e6e-ae348ec833251
543546nystatin 100,000 UNT/GM Topical CreamSY377b0312-abfe-45eb-9e6e-ae348ec833251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-7818-74006037818741 TUBE in 1 CARTON (0603-7818-74) > 15 g in 1 TUBE1 tube2006-05-312021-07-31NoNoCurrent
0603-7818-78006037818781 TUBE in 1 CARTON (0603-7818-78) > 30 g in 1 TUBE1 tube2006-05-312021-07-31NoNoCurrent
0603-7818-88006037818881 TUBE in 1 CARTON (0603-7818-88) > 60 g in 1 TUBE1 tube2006-05-312021-07-31NoNoCurrent