FDA.reportPublic FDA data

Nystatin

Product NDC
45802-048
11-digit product format
458020048
Labeler code
45802
Product ID
45802-048_d0882d4c-19ef-45d3-99c2-2697b1d213d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA062472
Marketing category
ANDA
Marketing start
2006-09-15
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
Rxcui884308

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-048-11Nystatin1 in 1 CARTONOINTMENT110
45802-048-11Nystatin30 g in 1 TUBEOINTMENT3010
45802-048-35Nystatin1 in 1 CARTONOINTMENT110
45802-048-35Nystatin15 g in 1 TUBEOINTMENT1510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-048-11GM - Gram45802-0481ee4e49b-b21e-4d04-a4c2-3f7e3d82747b12012-07-24
45802-048-35GM - Gram45802-0487b60fa1f-03d4-4706-a26f-6c900db3cad812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN OINTMENT [PERRIGO NEW YORK INC]5
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN OINTMENT [PERRIGO NEW YORK INC]5
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPNYSTATIN OINTMENT [PERRIGO NEW YORK INC]5
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN OINTMENT [PERRIGO NEW YORK INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-048NYSTATIN OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]10Current NDC, Legacy NDC, 4 package rows20250125_6c091c66-2e4d-4412-b7bf-35315dc8152f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884308nystatin 100,000 UNT/GM Topical OintmentPSN6c091c66-2e4d-4412-b7bf-35315dc8152f10
884308nystatin 100 UNT/MG Topical OintmentSCD6c091c66-2e4d-4412-b7bf-35315dc8152f10
884308nystatin 100,000 UNT/GM Topical OintmentSY6c091c66-2e4d-4412-b7bf-35315dc8152f10
884308nystatin 100,000 UNT/GM Topical OintmentPSN0ee89f89-e90d-4706-9fa5-a61b5fde44705
884308nystatin 100 UNT/MG Topical OintmentSCD0ee89f89-e90d-4706-9fa5-a61b5fde44705
884308nystatin 100,000 UNT/GM Topical OintmentSY0ee89f89-e90d-4706-9fa5-a61b5fde44705
884308nystatin 100,000 UNT/GM Topical OintmentPSN72dc2b60-29a4-48a8-848a-1a5086cfdd582
884308nystatin 100 UNT/MG Topical OintmentSCD72dc2b60-29a4-48a8-848a-1a5086cfdd582
884308nystatin 100,000 UNT/GM Topical OintmentSY72dc2b60-29a4-48a8-848a-1a5086cfdd582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-048-11458020048111 TUBE in 1 CARTON (45802-048-11) / 30 g in 1 TUBE1 tube2006-11-080000-00-00NoNoCurrent
45802-048-35458020048351 TUBE in 1 CARTON (45802-048-35) / 15 g in 1 TUBE1 tube2006-09-150000-00-00NoNoCurrent