FDA.reportPublic FDA data

Nystatin

Product NDC
51672-1289
11-digit product format
516721289
Labeler code
51672
Product ID
51672-1289_3908cf94-b2b6-30a4-e063-6394a90add43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA064022
Marketing category
ANDA
Marketing start
1993-01-28
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
51672-1289-1Nystatin15 g in 1 TUBECREAM156
51672-1289-1Nystatin1 in 1 CARTONCREAM16
51672-1289-2Nystatin1 in 1 CARTONCREAM16
51672-1289-2Nystatin30 g in 1 TUBECREAM306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1289-1GM - Gram51672-128938067616-cd05-468d-a844-b2ec0513e43f12012-07-24
51672-1289-2GM - Gram51672-12894f7b2183-b586-49ab-9a71-4e40d5479cb912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
algeldrateINACTIVE INGREDIENT03J11K103CNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
ceteareth-15INACTIVE INGREDIENT867H4YOZ8ZNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
sodium hydroxideINACTIVE INGREDIENT55X04QC32INYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
sorbitolINACTIVE INGREDIENT506T60A25RNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
ALGELDRATEINACTIVE INGREDIENT03J11K103CNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
ALGELDRATEINACTIVE INGREDIENT03J11K103CNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
CETEARETH-12INACTIVE INGREDIENT7V4MR24V5PNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
CETEARETH-15INACTIVE INGREDIENT867H4YOZ8ZNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32INYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
SORBITOLINACTIVE INGREDIENT506T60A25RNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1289NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 4 package rows20230126_4d845b3f-ca26-4c47-b424-b6d783cc10e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSN4d845b3f-ca26-4c47-b424-b6d783cc10e56
543546nystatin 100000 UNT/ML Topical CreamSCD4d845b3f-ca26-4c47-b424-b6d783cc10e56
543546nystatin 100,000 UNT/GM Topical CreamSY4d845b3f-ca26-4c47-b424-b6d783cc10e56
543546nystatin 100,000 UNT/GM Topical CreamPSN57825c04-dcb5-b76d-e053-2991aa0a4c1d4
543546nystatin 100,000 UNT/GM Topical CreamPSNcd387929-5b72-e3c0-e053-2a95a90adb224
543546nystatin 100000 UNT/ML Topical CreamSCD57825c04-dcb5-b76d-e053-2991aa0a4c1d4
543546nystatin 100000 UNT/ML Topical CreamSCDcd387929-5b72-e3c0-e053-2a95a90adb224
543546nystatin 100,000 UNT/GM Topical CreamSY57825c04-dcb5-b76d-e053-2991aa0a4c1d4
543546nystatin 100,000 UNT/GM Topical CreamSYcd387929-5b72-e3c0-e053-2a95a90adb224
543546nystatin 100,000 UNT/GM Topical CreamPSN5ef15e1c-66dc-4858-8552-d83e42c3883e3
543546nystatin 100,000 UNT/GM Topical CreamPSNcf6b7c68-7769-1808-e053-2995a90aa4263
543546nystatin 100000 UNT/ML Topical CreamSCD5ef15e1c-66dc-4858-8552-d83e42c3883e3
543546nystatin 100000 UNT/ML Topical CreamSCDcf6b7c68-7769-1808-e053-2995a90aa4263
543546nystatin 100,000 UNT/GM Topical CreamSYcf6b7c68-7769-1808-e053-2995a90aa4263
543546nystatin 100,000 UNT/GM Topical CreamSY5ef15e1c-66dc-4858-8552-d83e42c3883e3
543546nystatin 100,000 UNT/GM Topical CreamPSNbdb80797-20c8-4fbc-8ef8-b85d6aebdce51
543546nystatin 100000 UNT/ML Topical CreamSCDbdb80797-20c8-4fbc-8ef8-b85d6aebdce51
543546nystatin 100,000 UNT/GM Topical CreamSYbdb80797-20c8-4fbc-8ef8-b85d6aebdce51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1289-1516721289011 TUBE in 1 CARTON (51672-1289-1) / 15 g in 1 TUBE1 tube1993-01-280000-00-00NoNoCurrent
51672-1289-2516721289021 TUBE in 1 CARTON (51672-1289-2) / 30 g in 1 TUBE1 tube1993-01-280000-00-00NoNoCurrent