FDA.reportPublic FDA data

Nystatin

Product NDC
51672-4117
11-digit product format
516724117
Labeler code
51672
Product ID
51672-4117_29a58f9e-6262-8297-e063-6294a90ad86d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA062876
Marketing category
ANDA
Marketing start
1988-02-29
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
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]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDF1O1C72E
Rxcui312055

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4117-0Nystatin3785 mL in 1 BOTTLESUSPENSION37855
51672-4117-4Nystatin1 in 1 CARTONSUSPENSION15
51672-4117-4Nystatin60 mL in 1 BOTTLE, DROPPERSUSPENSION605
51672-4117-9Nystatin473 mL in 1 BOTTLESUSPENSION4735

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4117-4ML - Milliliter51672-41171e6de0b3-5749-4306-9fe0-0d91b55914dc12012-07-24
51672-4117-9ML - Milliliter51672-41175bb4cb9c-5fc2-478e-9530-83731a41dfde12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2
alcoholINACTIVE INGREDIENT3K9958V90MNYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2
benzaldehydeINACTIVE INGREDIENTTA269SD04TNYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2
edetate calcium disodiumINACTIVE INGREDIENT25IH6R4SGFNYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCNYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYNYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRNYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2
sucroseINACTIVE INGREDIENTC151H8M554NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RNYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2
xanthan gumINACTIVE INGREDIENTTTV12P4NEENYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4117NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 4 package rows20241222_01c469b3-ec10-452c-8c02-3e7d22e40297.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSN01c469b3-ec10-452c-8c02-3e7d22e402975
312055nystatin 100000 UNT/ML Oral SuspensionSCD01c469b3-ec10-452c-8c02-3e7d22e402975
312055nystatin 100,000 UNT/ML Oral SuspensionSY01c469b3-ec10-452c-8c02-3e7d22e402975
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY01c469b3-ec10-452c-8c02-3e7d22e402975
312055nystatin 100,000 UNT/mL Oral SuspensionPSNa0540f97-18a2-4dd5-b3a8-a899c3831f511
312055nystatin 100000 UNT/ML Oral SuspensionSCDa0540f97-18a2-4dd5-b3a8-a899c3831f511
312055nystatin 100,000 UNT/ML Oral SuspensionSYa0540f97-18a2-4dd5-b3a8-a899c3831f511
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYa0540f97-18a2-4dd5-b3a8-a899c3831f511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4117-0516724117003785 mL in 1 BOTTLE (51672-4117-0) 3785 ml1988-02-290000-00-00NoNoCurrent
51672-4117-4516724117041 BOTTLE, DROPPER in 1 CARTON (51672-4117-4) / 60 mL in 1 BOTTLE, DROPPER1988-02-290000-00-00NoNoCurrent
51672-4117-951672411709473 mL in 1 BOTTLE (51672-4117-9) 473 ml1988-02-290000-00-00NoNoCurrent