FDA.reportPublic FDA data

Nystatin

Product NDC
72578-089
11-digit product format
725780089
Labeler code
72578
Product ID
72578-089_3d917a6c-4e9a-4c45-9e79-caf91f8b11b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA207767
Marketing category
ANDA
Marketing start
2020-06-24
Substance
NYSTATIN
Active strength
100000 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 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
72578-089-01Nystatin15 g in 1 TUBEOINTMENT154
72578-089-04Nystatin30 g in 1 TUBEOINTMENT304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-089NYSTATIN OINTMENT [VIONA PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 2 package rows20221122_e135a7d2-adba-48a2-b3e1-07b778cce9b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884308nystatin 100,000 UNT/GM Topical OintmentPSN53d1c23b-9cf2-4941-8701-8a7da1b066cc102
884308nystatin 100,000 UNT/GM Topical OintmentPSN84383bc5-1282-43d6-9303-23c8fd8d075f102
884308nystatin 100 UNT/MG Topical OintmentSCD53d1c23b-9cf2-4941-8701-8a7da1b066cc102
884308nystatin 100 UNT/MG Topical OintmentSCD84383bc5-1282-43d6-9303-23c8fd8d075f102
884308nystatin 100,000 UNT/GM Topical OintmentSY53d1c23b-9cf2-4941-8701-8a7da1b066cc102
884308nystatin 100,000 UNT/GM Topical OintmentSY84383bc5-1282-43d6-9303-23c8fd8d075f102
884308nystatin 100,000 UNT/GM Topical OintmentPSN93d59122-86f3-489d-9790-1ef6c6aff89d101
884308nystatin 100 UNT/MG Topical OintmentSCD93d59122-86f3-489d-9790-1ef6c6aff89d101
884308nystatin 100,000 UNT/GM Topical OintmentSY93d59122-86f3-489d-9790-1ef6c6aff89d101
884308nystatin 100,000 UNT/GM Topical OintmentPSN6a3bb3da-adf9-46d2-a5ff-f796e7aae7a15
884308nystatin 100 UNT/MG Topical OintmentSCD6a3bb3da-adf9-46d2-a5ff-f796e7aae7a15
884308nystatin 100,000 UNT/GM Topical OintmentSY6a3bb3da-adf9-46d2-a5ff-f796e7aae7a15
884308nystatin 100,000 UNT/GM Topical OintmentPSNe135a7d2-adba-48a2-b3e1-07b778cce9b04
884308nystatin 100 UNT/MG Topical OintmentSCDe135a7d2-adba-48a2-b3e1-07b778cce9b04
884308nystatin 100,000 UNT/GM Topical OintmentSYe135a7d2-adba-48a2-b3e1-07b778cce9b04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-089-017257800890115 g in 1 TUBE (72578-089-01) 15 g2020-06-240000-00-00NoNoCurrent
72578-089-047257800890430 g in 1 TUBE (72578-089-04) 30 g2020-06-240000-00-00NoNoCurrent