FDA.reportPublic FDA data

NDC 63629-2065-01 - Rivastigmine Transdermal System

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
63629-2065
Requested NDC
63629-2065-01
Package NDCs from labels
63629-2065-2, 63629-2065-1, 63629-2065-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rivastigmine Transdermal System - Bryant Ranch PrepackBryant Ranch Prepack2024-08-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2065-1Rivastigmine Transdermal System30 in 1 CARTONPATCH, EXTENDED RELEASE30108
63629-2065-2Rivastigmine Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE1108
63629-2065-2Rivastigmine Transdermal System24 h in 1 PATCHPATCH, EXTENDED RELEASE24108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2065RIVASTIGMINE TRANSDERMAL SYSTEM (RIVASTIGMINE) PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]108Current NDC, Legacy NDC, 3 package rows20240820_82630f84-fb47-47ab-8ee2-1720a486de02.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2065-1EA - Each63629-20654286a6bb-9a74-46e3-8838-3882d256194812021-06-02

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
RivastigmineRIVASTIGMINEZydus Lifesciences Limited966d59ea-5cea-4fef-8b96-e0efe885caf42025-11-17Exact identifier
rxcui: 725021
rxcui: 1308569
rxcui: 725023
unii: PKI06M3IW0
RivastigmineRIVASTIGMINENorthstar Rx LLC.8b809739-8381-4cc1-ab4a-5b17ab902a3d2025-11-14Warnings, Adverse reactionsExact identifier
rxcui: 725021
rxcui: 1308569
rxcui: 725023
unii: PKI06M3IW0
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack8d8823c0-9339-4ec8-8a19-d13974b6614b2025-04-01Warnings, Adverse reactionsExact identifier
application number: ANDA209063
rxcui: 1308569
unii: PKI06M3IW0
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepacka7f9328e-b6da-4474-ac93-3cdd4825e1632025-04-01Warnings, Adverse reactionsExact identifier
application number: ANDA209063
rxcui: 725021
unii: PKI06M3IW0
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack5cd5c434-ffd0-4aed-9eba-145c86b115bb2025-03-27Warnings, Adverse reactionsExact identifier
application number: ANDA209063
rxcui: 1308569
unii: PKI06M3IW0
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepacka68d70c9-19f2-47db-bf78-4da04a87a7022025-03-20Warnings, Adverse reactionsExact identifier
application number: ANDA209063
rxcui: 725023
unii: PKI06M3IW0
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack6cc286d9-c5d4-4505-83bb-9015e30778512025-03-19Warnings, Adverse reactionsExact identifier
application number: ANDA209063
rxcui: 1308569
unii: PKI06M3IW0
Rivastigmine Transdermal SystemRIVASTIGMINEBreckenridge Pharmaceutical, Inc.b201fe68-b5e5-4a6f-8cf1-069543f03e762025-01-15Warnings, Adverse reactionsExact identifier
application number: ANDA209063
ndc (product): 51991-897
rxcui: 725021
rxcui: 1308569
rxcui: 725023
spl id: 6c0c606b-108e-4837-8533-f485f9e4ee4b
spl set id: b201fe68-b5e5-4a6f-8cf1-069543f03e76
unii: PKI06M3IW0
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack1ebeb8ec-5348-4bb1-ab3d-8346903510942024-12-24Warnings, Adverse reactionsExact identifier
application number: ANDA209063
rxcui: 725023
unii: PKI06M3IW0
RivastigmineRIVASTIGMINEMylan Pharmaceuticals Inc.4ab335d1-19ee-4cd9-9776-8086645d19e42024-09-21Warnings, Adverse reactionsExact identifier
rxcui: 725021
rxcui: 1308569
rxcui: 725023
unii: PKI06M3IW0
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack82630f84-fb47-47ab-8ee2-1720a486de022024-08-19Warnings, Adverse reactionsExact identifier
application number: ANDA209063
ndc (package): 63629-2065-1
ndc (package): 63629-2065-2
ndc (product): 63629-2065
ndc11 (package): 63629206501
rxcui: 725021
spl id: 514cd09f-04ed-46b0-8d34-802d6c0d969d
spl set id: 82630f84-fb47-47ab-8ee2-1720a486de02
unii: PKI06M3IW0
RivastigmineRIVASTIGMINEAmneal Pharmaceuticals LLC8b671fc9-8cb0-4406-a9ee-7c95086d62002024-07-02Warnings, Adverse reactionsExact identifier
rxcui: 725021
rxcui: 1308569
rxcui: 725023
unii: PKI06M3IW0
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepackc569f760-f311-42ba-909c-a36319622b352024-05-30Warnings, Adverse reactionsExact identifier
application number: ANDA209063
rxcui: 725023
unii: PKI06M3IW0
RivastigmineRIVASTIGMINEZydus Pharmaceuticals USA Inc.64dad603-2389-456b-8c18-d1d40b7e74192024-05-27Warnings, Adverse reactionsExact identifier
rxcui: 725021
rxcui: 1308569
rxcui: 725023
unii: PKI06M3IW0
RivastigmineRIVASTIGMINESandoz Inc92a58ebb-748d-49f4-bf11-ecbcf54241522024-05-08Warnings, Adverse reactionsExact identifier
rxcui: 725021
rxcui: 1308569
rxcui: 725023
unii: PKI06M3IW0
ExelonRIVASTIGMINENovartis Pharmaceuticals Corporation07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e02024-05-08Warnings, Adverse reactionsExact identifier
rxcui: 725021
rxcui: 1308569
rxcui: 725023
unii: PKI06M3IW0
ExelonRIVASTIGMINESandoz Incb6ed6d15-116d-4596-92ce-3414574d7ba02024-05-08Warnings, Adverse reactionsExact identifier
rxcui: 725021
rxcui: 1308569
rxcui: 725023
unii: PKI06M3IW0

Reported adverse events (FAERS/openFDA)#

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