FDA.reportPublic FDA data

Nystatin

Product NDC
72162-2496
11-digit product format
721622496
Labeler code
72162
Product ID
72162-2496_89ed46f6-8777-46e7-b60f-f1372031cf66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA213566
Marketing category
ANDA
Marketing start
2021-08-25
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
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
72162-2496-2Nystatin15 g in 1 TUBECREAM15101
72162-2496-2Nystatin1 in 1 CARTONCREAM1101
72162-2496-3Nystatin30 g in 1 TUBECREAM30101
72162-2496-3Nystatin1 in 1 CARTONCREAM1101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2496-2GM - Gram72162-249683d4118c-67c6-4fc0-b862-55c40f0b55be12025-06-13
72162-2496-3GM - Gram72162-24969a087610-02b9-46ab-95ca-cff6cd824e0912025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2496NYSTATIN CREAM [BRYANT RANCH PREPACK]100Current NDC, 4 package rows20250523_b6aa24e6-1acb-4fd3-9ec7-11b1a69c1598.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2496-2721622496021 TUBE in 1 CARTON (72162-2496-2) / 15 g in 1 TUBE1 tube2025-05-15NoNoHistorical
72162-2496-3721622496031 TUBE in 1 CARTON (72162-2496-3) / 30 g in 1 TUBE1 tube2025-05-15NoNoHistorical