FDA.reportPublic FDA data

Nystatin

Product NDC
60432-537
11-digit product format
604320537
Labeler code
60432
Product ID
60432-537_ae3ecbaa-1371-4b51-8abd-3a583c0de11b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nystatin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA062512
Marketing category
ANDA
Marketing start
1995-04-15
Marketing end
0000-00-00
Substance
NYSTATIN
Active strength
100000 [USP'U]/mL
Pharmacologic classes
Polyene Antifungal [EPC],Polyenes [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60432-537-162025-12-10C16284748780-1f386c649-a8f8-0266-e053-dadaa90a7c1ad468395c-0f4c-4503-9a39-ae847524e683
60432-537-602025-12-10C16284748780-1f386c649-a8f8-0266-e053-dadaa90a7c1ad468395c-0f4c-4503-9a39-ae847524e683
60432-537-162023-01-30C16284748780-1f386c649-a8f8-0266-e053-dadaa90a7c1ad468395c-0f4c-4503-9a39-ae847524e683
60432-537-602023-01-30C16284748780-1f386c649-a8f8-0266-e053-dadaa90a7c1ad468395c-0f4c-4503-9a39-ae847524e683

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-537-16ML - Milliliter60432-5374cade063-c2f1-481b-8ce0-2f183b5989df12012-07-24
60432-537-60ML - Milliliter60432-537a627d2f6-c5a2-4e15-80fc-69e008e6482b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
alcoholINACTIVE INGREDIENT3K9958V90MNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOANYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
potassium phosphate, dibasicINACTIVE INGREDIENTCI71S98N1ZNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
sucroseINACTIVE INGREDIENTC151H8M554NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
waterINACTIVE INGREDIENT059QF0KO0RNYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]3
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOANYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
POTASSIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTCI71S98N1ZNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
potassium phosphate, dibasicINACTIVE INGREDIENTCI71S98N1ZNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554NYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
sucroseINACTIVE INGREDIENTC151H8M554NYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RNYSTATIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RNYSTATIN SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-537NYSTATIN SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]4Legacy NDC20190124_d468395c-0f4c-4503-9a39-ae847524e683.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312055nystatin 100,000 UNT/mL Oral SuspensionPSNe069d495-7f1a-4970-8f4d-aa93d124b3fc9
312055nystatin 100000 UNT/ML Oral SuspensionSCDe069d495-7f1a-4970-8f4d-aa93d124b3fc9
312055nystatin 100,000 UNT/ML Oral SuspensionSYe069d495-7f1a-4970-8f4d-aa93d124b3fc9
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYe069d495-7f1a-4970-8f4d-aa93d124b3fc9
312055nystatin 100,000 UNT/mL Oral SuspensionPSN19af50e2-0535-44f4-8b31-49e0bfe6a4151
312055nystatin 100,000 UNT/mL Oral SuspensionPSNceb0fc2d-9039-4961-84b6-ceb2a2649c501
312055nystatin 100,000 UNT/mL Oral SuspensionPSNf7a98d15-ce46-4358-ac6e-d10afa4d34c21
312055nystatin 100000 UNT/ML Oral SuspensionSCD19af50e2-0535-44f4-8b31-49e0bfe6a4151
312055nystatin 100000 UNT/ML Oral SuspensionSCDceb0fc2d-9039-4961-84b6-ceb2a2649c501
312055nystatin 100000 UNT/ML Oral SuspensionSCDf7a98d15-ce46-4358-ac6e-d10afa4d34c21
312055nystatin 100,000 UNT/ML Oral SuspensionSY19af50e2-0535-44f4-8b31-49e0bfe6a4151
312055nystatin 100,000 UNT/ML Oral SuspensionSYceb0fc2d-9039-4961-84b6-ceb2a2649c501
312055nystatin 100,000 UNT/ML Oral SuspensionSYf7a98d15-ce46-4358-ac6e-d10afa4d34c21
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSY19af50e2-0535-44f4-8b31-49e0bfe6a4151
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYceb0fc2d-9039-4961-84b6-ceb2a2649c501
312055nystatin 500,000 UNT per 5 ML Oral SuspensionSYf7a98d15-ce46-4358-ac6e-d10afa4d34c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60432-537-1660432053716473 mL in 1 BOTTLE, PLASTIC (60432-537-16) 473 ml1995-04-150000-00-00NoNoCurrent
60432-537-606043205376060 mL in 1 BOTTLE, GLASS (60432-537-60) 60 ml1995-04-150000-00-00NoNoCurrent