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 5 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.90a58c0e-85cf-3aad-e053-2a95a90a316a2024-06-19Adverse reactionsExact identifier
unii: BDF1O1C72E
nystatin and triamcinolone acetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEBryant Ranch Prepack11ee6692-8b04-441b-a981-3a0c9352cbd12024-06-18Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEBryant Ranch Prepack3dab5155-9c86-464b-b41b-1507ff49a6942024-06-06Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATINNYSTATINLeading Pharma, LLC089e6444-2bd1-443e-acf0-dfeaa69faef92024-04-18Exact identifier
rxcui: 646456
unii: BDF1O1C72E
NystatinNYSTATINDr. Reddy's Labratories Inc.6bde84a1-341d-09ce-58b6-f9a653dc98c52024-04-12Adverse reactionsExact identifier
rxcui: 646456
unii: BDF1O1C72E
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepack6f25f129-a682-47d0-8788-bac21b65c8302024-03-29Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINBryant Ranch Prepack93d59122-86f3-489d-9790-1ef6c6aff89d2024-03-26Adverse reactionsExact identifier
unii: BDF1O1C72E
NystopNYSTATINBryant Ranch Prepack87175864-9877-4e80-b870-907abb8ac2892024-03-22Adverse reactionsExact identifier
application number: ANDA064118
ndc (package): 63629-8697-1
ndc (product): 63629-8697
ndc11 (package): 63629869701
rxcui: 261178
rxcui: 646456
spl id: bc867e0d-e4f6-47bc-b074-8417f83fbdc0
spl set id: 87175864-9877-4e80-b870-907abb8ac289
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEBryant Ranch Prepackf3e21d77-7ca9-4ca9-97f9-b394f7202aa62024-03-14Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINPadagis Israel Pharmaceuticals Ltde630aa3d-11a6-4300-942a-cbdf2d016f772024-03-01Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINAmerican Health Packagingd8c251a6-d4da-4664-bff4-6868541d11782024-02-22Adverse reactionsExact identifier
unii: BDF1O1C72E
NystopNYSTATINBryant Ranch Prepack5bce98a3-2964-4edc-b8da-8a46dafadf5e2024-01-11Adverse reactionsExact identifier
application number: ANDA064118
rxcui: 261178
rxcui: 646456
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEAlembic Pharmaceuticals Inc.1034d417-493a-443a-a62e-30786f673ee32023-12-12Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEAlembic Pharmaceuticals Inc.91546bba-d141-4a3b-a4e7-15de2282e7e52023-12-12Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINProficient Rx LP8566c432-741f-4af7-91d7-1b7668ce5e952023-12-01Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATIN OINTMENTCosette Pharmaceuticals, Inc.8f87de59-33f2-32af-ae17-78bf30fb424d2023-11-29Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINA-S Medication Solutions6a3bb3da-adf9-46d2-a5ff-f796e7aae7a12023-11-24Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATINNYSTATINZydus Pharmaceuticals USA Inc.2daf159d-6a12-4b5d-97b3-8069c17e76352023-11-04Adverse reactionsExact identifier
rxcui: 646456
unii: BDF1O1C72E
NystatinNYSTATINActavis Pharma, Inc.aee7ce4c-8cc6-4446-a4d7-63bc4773066f2023-10-30Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINA-S Medication Solutionscc3516cd-985c-489f-b4a1-8477876c5a972023-10-19Adverse reactionsExact identifier
unii: BDF1O1C72E

Reported adverse events (FAERS/openFDA)#

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