FDA.reportPublic FDA data

NYSTATIN

Product NDC
59651-907
11-digit product format
596510907
Labeler code
59651
Product ID
59651-907_1a24e1d4-b691-4849-822a-9a9a4aed4b27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NYSTATIN
Dosage form
CREAM
Route
TOPICAL
Labeler
Aurobindo Pharma Limited
Application
ANDA219527
Marketing category
ANDA
Marketing start
2025-03-21
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
59651-907-14NYSTATIN1 in 1 CARTONCREAM12
59651-907-14NYSTATIN15 g in 1 TUBECREAM152
59651-907-30NYSTATIN30 g in 1 TUBECREAM302
59651-907-30NYSTATIN1 in 1 CARTONCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-907-14GM - Gram59651-907bf17e99f-b70a-460a-897d-98bbb549102612026-01-08
59651-907-30GM - Gram59651-9079578b7ad-eb7f-4667-b5c6-95f0216884b612026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-907NYSTATIN CREAM [AUROBINDO PHARMA LIMITED]1Current NDC, 4 package rows20250403_7d8a30ab-465e-4804-a06b-afd689e16683.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSN7d8a30ab-465e-4804-a06b-afd689e166832
543546nystatin 100000 UNT/ML Topical CreamSCD7d8a30ab-465e-4804-a06b-afd689e166832
543546nystatin 100,000 UNT/GM Topical CreamSY7d8a30ab-465e-4804-a06b-afd689e166832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-907-14596510907141 TUBE in 1 CARTON (59651-907-14) / 15 g in 1 TUBE1 tube2025-03-21NoNoHistorical
59651-907-30596510907301 TUBE in 1 CARTON (59651-907-30) / 30 g in 1 TUBE1 tube2025-03-21NoNoHistorical