FDA.reportPublic FDA data

Nystatin

Product NDC
33342-469
11-digit product format
333420469
Labeler code
33342
Product ID
33342-469_d8ebb61a-a326-4f0d-a346-c3db045c3fb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA213566
Marketing category
ANDA
Marketing start
2021-08-25
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
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
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
33342-469-15Nystatin15 g in 1 TUBECREAM151
33342-469-15Nystatin1 in 1 CARTONCREAM11
33342-469-30Nystatin1 in 1 CARTONCREAM11
33342-469-30Nystatin30 g in 1 TUBECREAM301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-469-15GM - Gram33342-469cc2bb624-0764-45a0-8db6-560a89e5713512022-01-06
33342-469-30GM - Gram33342-469a8b2ec6b-f766-4747-a682-177cf38557fb12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-469NYSTATIN CREAM [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, Legacy NDC, 4 package rows20210826_d8ebb61a-a326-4f0d-a346-c3db045c3fb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSNb6aa24e6-1acb-4fd3-9ec7-11b1a69c1598101
543546nystatin 100000 UNT/ML Topical CreamSCDb6aa24e6-1acb-4fd3-9ec7-11b1a69c1598101
543546nystatin 100,000 UNT/GM Topical CreamSYb6aa24e6-1acb-4fd3-9ec7-11b1a69c1598101
543546nystatin 100,000 UNT/GM Topical CreamPSNd8ebb61a-a326-4f0d-a346-c3db045c3fb01
543546nystatin 100000 UNT/ML Topical CreamSCDd8ebb61a-a326-4f0d-a346-c3db045c3fb01
543546nystatin 100,000 UNT/GM Topical CreamSYd8ebb61a-a326-4f0d-a346-c3db045c3fb01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-469-15333420469151 TUBE in 1 CARTON (33342-469-15) / 15 g in 1 TUBE1 tube2021-08-250000-00-00NoNoCurrent
33342-469-30333420469301 TUBE in 1 CARTON (33342-469-30) / 30 g in 1 TUBE1 tube2021-08-250000-00-00NoNoCurrent