FDA.reportPublic FDA data

Nystatin

Product NDC
0603-1481
11-digit product format
006031481
Labeler code
0603
Product ID
0603-1481_2d6bac60-67d9-4b1b-a007-660ed3528b41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Par Pharmaceutical
Application
ANDA065148
Marketing category
ANDA
Marketing start
2005-06-28
Marketing end
2019-04-30
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-1481-49ML - Milliliter0603-14811b0e5187-a61c-49a2-8770-ed137e2f0d7312012-07-24
0603-1481-58ML - Milliliter0603-1481c53f8969-0b36-4431-8610-50917d22273a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [STAT RX USA LLC]1
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [STAT RX USA LLC]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MNYSTATIN SUSPENSION [STAT RX USA LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNYSTATIN SUSPENSION [STAT RX USA LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311NYSTATIN SUSPENSION [STAT RX USA LLC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [STAT RX USA LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [STAT RX USA LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN SUSPENSION [STAT RX USA LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYNYSTATIN SUSPENSION [STAT RX USA LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNYSTATIN SUSPENSION [STAT RX USA LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554NYSTATIN SUSPENSION [STAT RX USA LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RNYSTATIN SUSPENSION [STAT RX USA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSNe73b5b84-7af5-4778-bcb3-71e573ce3c504
312055nystatin 100000 UNT/ML Oral SuspensionSCDe73b5b84-7af5-4778-bcb3-71e573ce3c504
312055nystatin 100,000 UNT/ML Oral SuspensionSYe73b5b84-7af5-4778-bcb3-71e573ce3c504
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYe73b5b84-7af5-4778-bcb3-71e573ce3c504
312055nystatin 100,000 UNT/mL Oral SuspensionPSN29ccf947-91c1-405a-aba6-5889e3c75d701
312055nystatin 100,000 UNT/mL Oral SuspensionPSN4c25ae58-c424-44c1-85e0-63b99ecd2ecb1
312055nystatin 100000 UNT/ML Oral SuspensionSCD29ccf947-91c1-405a-aba6-5889e3c75d701
312055nystatin 100000 UNT/ML Oral SuspensionSCD4c25ae58-c424-44c1-85e0-63b99ecd2ecb1
312055nystatin 100,000 UNT/ML Oral SuspensionSY29ccf947-91c1-405a-aba6-5889e3c75d701
312055nystatin 100,000 UNT/ML Oral SuspensionSY4c25ae58-c424-44c1-85e0-63b99ecd2ecb1
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY29ccf947-91c1-405a-aba6-5889e3c75d701
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY4c25ae58-c424-44c1-85e0-63b99ecd2ecb1