FDA.reportPublic FDA data

Nystatin

Product NDC
33342-481
11-digit product format
333420481
Labeler code
33342
Product ID
33342-481_fe3db8b2-9de4-4f9e-b763-8536a1e4cea8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA213826
Marketing category
ANDA
Marketing start
2021-01-29
Substance
NYSTATIN
Active strength
100000 1/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 1/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
33342-481-15Nystatin1 in 1 CARTONOINTMENT11
33342-481-15Nystatin15 g in 1 TUBEOINTMENT151
33342-481-30Nystatin30 g in 1 TUBEOINTMENT301
33342-481-30Nystatin1 in 1 CARTONOINTMENT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-481-15GM - Gram33342-4814517f113-4aca-48ef-a820-03b3d501b46112021-10-08
33342-481-30GM - Gram33342-481d39ba543-8b61-4a65-8fdc-e311a219dc1d12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-481NYSTATIN OINTMENT [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, Legacy NDC, 4 package rows20210130_fe3db8b2-9de4-4f9e-b763-8536a1e4cea8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884308nystatin 100,000 UNT/GM Topical OintmentPSNfe3db8b2-9de4-4f9e-b763-8536a1e4cea81
884308nystatin 100 UNT/MG Topical OintmentSCDfe3db8b2-9de4-4f9e-b763-8536a1e4cea81
884308nystatin 100,000 UNT/GM Topical OintmentSYfe3db8b2-9de4-4f9e-b763-8536a1e4cea81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-481-15333420481151 TUBE in 1 CARTON (33342-481-15) / 15 g in 1 TUBE1 tube2021-01-290000-00-00NoNoCurrent
33342-481-30333420481301 TUBE in 1 CARTON (33342-481-30) / 30 g in 1 TUBE1 tube2021-01-290000-00-00NoNoCurrent