FDA.reportPublic FDA data

NDC 49884-900-98 - Nystatin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49884-900
Requested NDC
49884-900-98
Package NDCs from labels
49884-900-98, 49884-900-18
Manufacturer
Par Pharmaceutical Inc.
Effective date
2007-08-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nystatin - Par Pharmaceutical Inc.Par Pharmaceutical Inc.2007-08-10HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-900-18Nystatin15 g in 1 BOTTLE, PLASTICPOWDER152
49884-900-98Nystatin56.7 g in 1 BOTTLE, PLASTICPOWDER56.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-900NYSTATIN (NYSTATIN) POWDER [PAR PHARMACEUTICAL INC.]22 package rows20070914_e5d3d8e4-3a92-4ac0-8918-d3209a30c12b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN (NYSTATIN) POWDER [PAR PHARMACEUTICAL INC.]2
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN (NYSTATIN) POWDER [PAR PHARMACEUTICAL INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UNYSTATIN (NYSTATIN) POWDER [PAR PHARMACEUTICAL INC.]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystopNYSTATINBryant Ranch Prepack0bb31239-fb77-442a-a9ee-ba61b45e7e682026-07-14Adverse reactionsExact identifier
rxcui: 646456
KLAYESTANYSTATIN TOPICAL POWDEREpic Pharma, LLC0df13b1e-0e07-4123-a83a-1d7afb56170f2025-12-17Adverse reactionsExact identifier
rxcui: 646456
NystopNYSTATINBryant Ranch Prepack64041bdf-1207-47f6-93f3-bc4656a7d2ae2025-10-21Adverse reactionsExact identifier
rxcui: 646456
NystopNYSTATINBryant Ranch Prepackaffea013-4f09-4e7d-a696-9f501d379af62025-10-21Adverse reactionsExact identifier
rxcui: 646456
NystatinNYSTATINNorthstar Rx LLC9e6d0b0d-a68f-46aa-a707-3110ecb931b42025-09-30Adverse reactionsExact identifier
rxcui: 646456
NystopNYSTATINBryant Ranch Prepack69ebb4dd-f45d-448d-97cd-3f89354939752025-08-26Adverse reactionsExact identifier
rxcui: 646456
NyamycNYSTATINUpsher-Smith Laboratories, LLC01b44f91-9b68-464a-9693-b5d3e793bf3c2025-07-09Adverse reactionsExact identifier
rxcui: 646456
NYSTATINNYSTATINZydus Lifesciences Limited5d593aa9-f2e4-4adf-9f02-37832ffcb5b42024-12-03Exact identifier
rxcui: 646456
NystopNYSTATINPadagis US LLCe1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f2024-10-31Adverse reactionsExact identifier
rxcui: 646456
NYSTATINNYSTATINLeading Pharma, LLC089e6444-2bd1-443e-acf0-dfeaa69faef92024-04-18Exact identifier
rxcui: 646456
NystatinNYSTATINDr. Reddy's Labratories Inc.6bde84a1-341d-09ce-58b6-f9a653dc98c52024-04-12Adverse reactionsExact identifier
rxcui: 646456
NystopNYSTATINBryant Ranch Prepack87175864-9877-4e80-b870-907abb8ac2892024-03-22Adverse reactionsExact identifier
rxcui: 646456
NystopNYSTATINBryant Ranch Prepack5bce98a3-2964-4edc-b8da-8a46dafadf5e2024-01-11Adverse reactionsExact identifier
rxcui: 646456
NYSTATINNYSTATINZydus Pharmaceuticals USA Inc.2daf159d-6a12-4b5d-97b3-8069c17e76352023-11-04Adverse reactionsExact identifier
rxcui: 646456
Nystatin Topical PowderNYSTATIN TOPICAL POWDEREpic Pharma, LLCfb2a480e-0bb1-445e-bbb6-701dea6dc6312023-08-10Adverse reactionsExact identifier
rxcui: 646456
Nystatin Topical PowderNYSTATIN TOPICAL POWDEREpic Pharma, LLC7f313a3b-7a4c-47fb-ad9f-e267514db5272018-05-02Adverse reactionsExact identifier
rxcui: 646456
3763536D-794E-310E-E9F1-48F105BB9457e5d3d8e4-3a92-4ac0-8918-d3209a30c12b2007-08-10Adverse reactionsExact identifier
spl id: 3763536D-794E-310E-E9F1-48F105BB9457
spl set id: e5d3d8e4-3a92-4ac0-8918-d3209a30c12b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.