FDA.reportPublic FDA data

Nystatin

Product NDC
45802-059
11-digit product format
458020059
Labeler code
45802
Product ID
45802-059_e2839c50-5b8f-4e7b-9636-d22687038a89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA062225
Marketing category
ANDA
Marketing start
2006-09-21
Substance
NYSTATIN
Active strength
100000 [USP'U]/g
Pharmacologic classes
Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nystatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN100000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui543546

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-059-11Nystatin30 g in 1 TUBECREAM309
45802-059-11Nystatin1 in 1 CARTONCREAM19
45802-059-35Nystatin1 in 1 CARTONCREAM19
45802-059-35Nystatin15 g in 1 TUBECREAM159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-059-11GM - Gram45802-059867bfc81-7571-439d-8e29-bd6fe3f624b412012-07-24
45802-059-35GM - Gram45802-059f9fbf1be-2ac4-45ed-9f94-443167bcfeff12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [PERRIGO NEW YORK INC]4
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [PERRIGO NEW YORK INC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNYSTATIN CREAM [PERRIGO NEW YORK INC]4
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSNYSTATIN CREAM [PERRIGO NEW YORK INC]4
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATNYSTATIN CREAM [PERRIGO NEW YORK INC]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INYSTATIN CREAM [PERRIGO NEW YORK INC]4
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BNYSTATIN CREAM [PERRIGO NEW YORK INC]4
WATERINACTIVE INGREDIENT059QF0KO0RNYSTATIN CREAM [PERRIGO NEW YORK INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-059NYSTATIN CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]9Current NDC, Legacy NDC, 4 package rows20240302_e630aa3d-11a6-4300-942a-cbdf2d016f77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSNb69d9035-bdf5-4c5a-94d8-f8438f6f0567107
543546nystatin 100000 UNT/ML Topical CreamSCDb69d9035-bdf5-4c5a-94d8-f8438f6f0567107
543546nystatin 100,000 UNT/GM Topical CreamSYb69d9035-bdf5-4c5a-94d8-f8438f6f0567107
543546nystatin 100,000 UNT/GM Topical CreamPSN840eebe8-5de2-40c5-acfd-03a98b2e790e105
543546nystatin 100000 UNT/ML Topical CreamSCD840eebe8-5de2-40c5-acfd-03a98b2e790e105
543546nystatin 100,000 UNT/GM Topical CreamSY840eebe8-5de2-40c5-acfd-03a98b2e790e105
543546nystatin 100,000 UNT/GM Topical CreamPSNcc8f9a06-cd1b-40e9-bc22-7e19f6d89b83102
543546nystatin 100000 UNT/ML Topical CreamSCDcc8f9a06-cd1b-40e9-bc22-7e19f6d89b83102
543546nystatin 100,000 UNT/GM Topical CreamSYcc8f9a06-cd1b-40e9-bc22-7e19f6d89b83102
543546nystatin 100,000 UNT/GM Topical CreamPSNb71356cf-7b6e-4ca0-9571-c80fd0d846cb100
543546nystatin 100000 UNT/ML Topical CreamSCDb71356cf-7b6e-4ca0-9571-c80fd0d846cb100
543546nystatin 100,000 UNT/GM Topical CreamSYb71356cf-7b6e-4ca0-9571-c80fd0d846cb100
543546nystatin 100,000 UNT/GM Topical CreamPSNf1b13a36-c349-4e26-a322-3ec02c61015515
543546nystatin 100000 UNT/ML Topical CreamSCDf1b13a36-c349-4e26-a322-3ec02c61015515
543546nystatin 100,000 UNT/GM Topical CreamSYf1b13a36-c349-4e26-a322-3ec02c61015515
543546nystatin 100,000 UNT/GM Topical CreamPSNf410ba07-9183-40a8-a2a6-46d3e976147012
543546nystatin 100000 UNT/ML Topical CreamSCDf410ba07-9183-40a8-a2a6-46d3e976147012
543546nystatin 100,000 UNT/GM Topical CreamSYf410ba07-9183-40a8-a2a6-46d3e976147012
543546nystatin 100,000 UNT/GM Topical CreamPSNe630aa3d-11a6-4300-942a-cbdf2d016f779
543546nystatin 100000 UNT/ML Topical CreamSCDe630aa3d-11a6-4300-942a-cbdf2d016f779
543546nystatin 100,000 UNT/GM Topical CreamSYe630aa3d-11a6-4300-942a-cbdf2d016f779
543546nystatin 100,000 UNT/GM Topical CreamPSN6599b544-60bd-ab30-e053-2a91aa0a67b66
543546nystatin 100,000 UNT/GM Topical CreamPSNe7f0e152-233a-492e-a297-7bf2c543c1136
543546nystatin 100000 UNT/ML Topical CreamSCD6599b544-60bd-ab30-e053-2a91aa0a67b66
543546nystatin 100000 UNT/ML Topical CreamSCDe7f0e152-233a-492e-a297-7bf2c543c1136
543546nystatin 100,000 UNT/GM Topical CreamSY6599b544-60bd-ab30-e053-2a91aa0a67b66
543546nystatin 100,000 UNT/GM Topical CreamSYe7f0e152-233a-492e-a297-7bf2c543c1136
543546nystatin 100,000 UNT/GM Topical CreamPSN86cfb84c-dcd3-b229-e053-2a91aa0aed5c3
543546nystatin 100000 UNT/ML Topical CreamSCD86cfb84c-dcd3-b229-e053-2a91aa0aed5c3
543546nystatin 100,000 UNT/GM Topical CreamSY86cfb84c-dcd3-b229-e053-2a91aa0aed5c3
543546nystatin 100,000 UNT/GM Topical CreamPSN14d15349-a888-40ca-977d-105718e79fbb2
543546nystatin 100000 UNT/ML Topical CreamSCD14d15349-a888-40ca-977d-105718e79fbb2
543546nystatin 100,000 UNT/GM Topical CreamSY14d15349-a888-40ca-977d-105718e79fbb2
543546nystatin 100,000 UNT/GM Topical CreamPSN23a026fe-0d5e-c1d8-e063-6394a90a5e781
543546nystatin 100,000 UNT/GM Topical CreamPSN239fb615-b7c0-04ec-e063-6394a90aad261
543546nystatin 100000 UNT/ML Topical CreamSCD23a026fe-0d5e-c1d8-e063-6394a90a5e781
543546nystatin 100000 UNT/ML Topical CreamSCD239fb615-b7c0-04ec-e063-6394a90aad261
543546nystatin 100,000 UNT/GM Topical CreamSY23a026fe-0d5e-c1d8-e063-6394a90a5e781
543546nystatin 100,000 UNT/GM Topical CreamSY239fb615-b7c0-04ec-e063-6394a90aad261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-059-11458020059111 TUBE in 1 CARTON (45802-059-11) / 30 g in 1 TUBE1 tube2006-09-210000-00-00NoNoCurrent
45802-059-35458020059351 TUBE in 1 CARTON (45802-059-35) / 15 g in 1 TUBE1 tube2007-01-250000-00-00NoNoCurrent