FDA.reportPublic FDA data

NDC 63629-8697-01 - Nystop

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
63629-8697
Requested NDC
63629-8697-01
Package NDCs from labels
63629-8697-1, 63629-8697-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-03-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nystop - Bryant Ranch PrepackBryant Ranch Prepack2024-03-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8697-1Nystop30 g in 1 BOTTLE, PLASTICPOWDER30105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8697NYSTOP (NYSTATIN) POWDER [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20240814_87175864-9877-4e80-b870-907abb8ac289.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8697-1GM - Gram63629-8697e4bc5942-d7fd-44fa-b5dc-622beec6e56d12021-10-08

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 4 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINPadagis Israel Pharmaceuticals Ltd6c091c66-2e4d-4412-b7bf-35315dc8152f2025-01-23Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATINNYSTATINDIRECT RXcd387929-5b72-e3c0-e053-2a95a90adb222025-01-20Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.6115a76d-4bad-4829-b2bc-3a077154109d2025-01-20Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATINNYSTATINNuCare Pharmaceuticals,Inc.0b4dfd5e-641e-40e9-e063-6294a90a3fda2025-01-03Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATINNYSTATINZydus Lifesciences Limited5d593aa9-f2e4-4adf-9f02-37832ffcb5b42024-12-03Exact identifier
rxcui: 646456
unii: BDF1O1C72E
NYSTATINNYSTATINLeading Pharma, LLC954205d8-47ba-4c89-95cd-f0066a514cf92024-11-28Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINNuCare Pharmaceuticals,Inc.6599b544-60bd-ab30-e053-2a91aa0a67b62024-11-20Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEBryant Ranch Prepackec28a12b-96f8-44ff-a440-8cff34ac20952024-11-06Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINA-S Medication Solutionsf410ba07-9183-40a8-a2a6-46d3e97614702024-11-06Adverse reactionsExact identifier
unii: BDF1O1C72E
NystopNYSTATINPadagis US LLCe1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f2024-10-31Adverse reactionsExact identifier
application number: ANDA064118
ndc (product): 0574-2008
rxcui: 261178
rxcui: 646456
spl id: d0aa24d2-89e9-4067-80f7-97a14ac1c21f
spl set id: e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f
unii: BDF1O1C72E
NystatinNYSTATINA-S Medication Solutions65167baa-29f8-44d3-b2d2-935c862d463e2024-10-16Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.c8beaa42-eb3a-d160-e053-2a95a90a31082024-10-03Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINBryant Ranch Prepackb69d9035-bdf5-4c5a-94d8-f8438f6f05672024-08-27Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepackb3056a63-d149-4ed4-84bc-918f5ff94a622024-08-22Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEBryant Ranch Prepackc62979d3-c9a4-4d94-956e-30760266daf42024-08-20Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEZydus Lifesciences Limited7b878bc9-9a6f-41b8-9d5a-287c01d8cf7f2024-08-16Exact identifier
unii: BDF1O1C72E
NystatinNYSTATINZydus Lifesciences Limited6aa2f67e-9636-45e5-be1b-83e7ab86e4362024-08-16Exact identifier
unii: BDF1O1C72E
NystatinNYSTATINNuCare Pharmaceuticals,Inc.57825c04-dcb5-b76d-e053-2991aa0a4c1d2024-08-14Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINNuCare Pharmaceuticals,Inc.86cfb84c-dcd3-b229-e053-2a91aa0aed5c2024-08-14Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepack92b08b14-a933-454b-8b6f-4b5e7c6829532024-08-06Adverse reactionsExact identifier
unii: BDF1O1C72E

Reported adverse events (FAERS/openFDA)#

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