FDA.reportPublic FDA data

Nystatin

Product NDC
72162-2333
11-digit product format
721622333
Labeler code
72162
Product ID
72162-2333_c4299118-f831-4982-a864-b8cb9d4c363d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bryant Ranch Prepack
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
72162-2333-2Nystatin15 g in 1 TUBEOINTMENT152
72162-2333-2Nystatin1 in 1 CARTONOINTMENT12
72162-2333-3Nystatin1 in 1 CARTONOINTMENT12
72162-2333-3Nystatin30 g in 1 TUBEOINTMENT302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2333-2GM - Gram72162-2333c9cff8c1-315c-4809-b52f-28b3f16e488e12024-07-12
72162-2333-3GM - Gram72162-2333c55f95e5-6af5-4aab-be15-de16ab47393f12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2333NYSTATIN OINTMENT [BRYANT RANCH PREPACK]2Current NDC, 4 package rows20250406_72dc2b60-29a4-48a8-848a-1a5086cfdd58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
72162-2333-2721622333021 TUBE in 1 CARTON (72162-2333-2) / 15 g in 1 TUBE1 tube2024-06-18NoNoHistorical
72162-2333-3721622333031 TUBE in 1 CARTON (72162-2333-3) / 30 g in 1 TUBE1 tube2024-06-18NoNoHistorical