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 3 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINBryant Ranch Prepackb6aa24e6-1acb-4fd3-9ec7-11b1a69c15982025-10-08Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINNorthstar Rx LLC9e6d0b0d-a68f-46aa-a707-3110ecb931b42025-09-30Adverse reactionsExact identifier
application number: ANDA064118
rxcui: 646456
unii: BDF1O1C72E
NystatinNYSTATINBryant Ranch Prepack840eebe8-5de2-40c5-acfd-03a98b2e790e2025-09-23Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINAvKARE8fd35f97-5405-2160-ca0f-35034ecd5a922025-09-18Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEEncube Ethicals, Inc.d33829fc-86df-4e28-82c3-9dbcd8a9e28d2025-08-29Adverse reactionsExact identifier
unii: BDF1O1C72E
NystopNYSTATINBryant Ranch Prepack69ebb4dd-f45d-448d-97cd-3f89354939752025-08-26Adverse reactionsExact identifier
application number: ANDA064118
rxcui: 261178
rxcui: 646456
unii: BDF1O1C72E
nystatinNYSTATINBryant Ranch Prepacka5711dbe-f71c-435c-91f2-38c357532d182025-08-19Adverse reactionsExact identifier
unii: BDF1O1C72E
NyamycNYSTATINUpsher-Smith Laboratories, LLC01b44f91-9b68-464a-9693-b5d3e793bf3c2025-07-09Adverse reactionsExact identifier
rxcui: 646456
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDESun Pharmaceutical Industries, Inc.2fd97fc5-cae5-43dd-a3c7-c9a03876153e2025-07-07Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINSun Pharmaceutical Industries, Inc.4d845b3f-ca26-4c47-b424-b6d783cc10e52025-07-03Adverse reactionsExact identifier
unii: BDF1O1C72E
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
nystatinNYSTATINHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.e87b8480-987d-4f82-87bf-cf831d6984a12025-06-23Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATINNYSTATINAurobindo Pharma Limited7d8a30ab-465e-4804-a06b-afd689e166832025-06-18Adverse reactionsExact identifier
unii: BDF1O1C72E
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
NystatinNYSTATINA-S Medication Solutionsa1b5ccb2-d0d6-46cc-b792-6920b50d0a032025-05-15Adverse reactionsExact identifier
unii: BDF1O1C72E
NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN, TRIAMCINOLONE ACETONIDEBryant Ranch Prepackc82fc464-d021-4a7c-8141-46d3d80134a22025-05-07Adverse reactionsExact identifier
unii: BDF1O1C72E
Nystatin and Triamcinolone AcetonideNYSTATIN AND TRIAMCINOLONE ACETONIDEAlembic Pharmaceuticals Limited51966a3b-dc09-4f41-941f-0f9247974d882025-04-08Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINBryant Ranch Prepack72dc2b60-29a4-48a8-848a-1a5086cfdd582025-04-03Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINBryant Ranch Prepackcc8f9a06-cd1b-40e9-bc22-7e19f6d89b832025-04-02Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINNuCare Pharmaceuticals,Inc.cf6b7c68-7769-1808-e053-2995a90aa4262025-02-10Adverse reactionsExact identifier
unii: BDF1O1C72E

Reported adverse events (FAERS/openFDA)#

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