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 2 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nystatin Oral SuspensionNYSTATINXttrium Laboratories, Inc.4a670371-d373-1ba6-e063-6394a90a13b62026-02-06Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINRedPharm Drug, Incf4c298d5-b012-7b56-e053-2a95a90a3d552026-01-24Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and triamcinolone acetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.c529567b-7061-4389-8c7a-20ef2b22c5912026-01-16Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEREMEDYREPACK INC.ea065dd4-dfd3-46a2-92de-8a0b49cb94552026-01-14Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATINNYSTATINATLANTIC BIOLOGICALS CORP.5c08148f-83e5-4f14-b0d3-af8d2c26062e2026-01-13Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin CreamNYSTATIN CREAMCrown Laboratories5a2b6fee-1437-0c3a-e053-2991aa0a34432026-01-12Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDECrown Laboratories54aae5d3-e482-4da0-a1b2-0ed70e6c29152026-01-12Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINChartwell RX, LLC30175930-f5fa-403d-a3ac-3bdbbe7236412025-12-17Adverse reactionsExact identifier
unii: BDF1O1C72E
KLAYESTANYSTATIN TOPICAL POWDEREpic Pharma, LLC0df13b1e-0e07-4123-a83a-1d7afb56170f2025-12-17Adverse reactionsExact identifier
rxcui: 646456
unii: BDF1O1C72E
NYSTATINNYSTATINKesin Pharma Corporation43817169-bbe8-58ee-e063-6294a90a12502025-12-11Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDELupin Pharmaceuticals, Inc.09140e74-c5ea-4c45-a5b1-e6f7f9ee1a232025-11-28Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINChartwell Governmental & Specialty RX, LLC88a0a22e-8d6b-42aa-b225-2d57fb5b3a972025-11-12Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATIN CREAMNuCare Pharmaceuticals, Inc.42f21220-c68a-d748-e063-6394a90a1e2f2025-11-06Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepackf81f461b-54cd-45bf-bf96-da77a5edc1e62025-10-28Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINBryant Ranch Prepackb71356cf-7b6e-4ca0-9571-c80fd0d846cb2025-10-23Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINCardinal Health 107, LLC56aca0e2-8691-4701-beba-e2315524709f2025-10-23Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEBryant Ranch Prepackd36c64f7-5481-45e4-ac9c-e16ae2194c6e2025-10-22Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEBryant Ranch Prepack26fd7fb6-6eeb-47f1-bbc4-001e84f996252025-10-22Adverse reactionsExact identifier
unii: BDF1O1C72E
NystopNYSTATINBryant Ranch Prepack64041bdf-1207-47f6-93f3-bc4656a7d2ae2025-10-21Adverse reactionsExact identifier
application number: ANDA064118
rxcui: 261178
rxcui: 646456
unii: BDF1O1C72E
NystopNYSTATINBryant Ranch Prepackaffea013-4f09-4e7d-a696-9f501d379af62025-10-21Adverse reactionsExact identifier
application number: ANDA064118
rxcui: 261178
rxcui: 646456
unii: BDF1O1C72E

Reported adverse events (FAERS/openFDA)#

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