FDA.reportPublic FDA data

Rivastigmine Transdermal System

Product NDC
63629-2065
11-digit product format
636292065
Labeler code
63629
Product ID
63629-2065_514cd09f-04ed-46b0-8d34-802d6c0d969d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Bryant Ranch Prepack
Application
ANDA209063
Marketing category
ANDA
Marketing start
2019-12-19
Substance
RIVASTIGMINE
Active strength
4.6 mg/24h
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rivastigmine Transdermal System
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIVASTIGMINE4.6 mg/24h

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPKI06M3IW0
Rxcui725021

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f5a24cc0-a293-4838-b663-7e454a66c2c3Product name520200513
64bcf1db-afe4-78b0-8e9c-f7cb25e1b791Product name620171121

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemPSN82630f84-fb47-47ab-8ee2-1720a486de02108
72502124 HR rivastigmine 0.192 MG/HR Transdermal SystemSCD82630f84-fb47-47ab-8ee2-1720a486de02108
725021rivastigmine 0.192 MG/HR 24 HR Transdermal PatchSY82630f84-fb47-47ab-8ee2-1720a486de02108
725021rivastigmine 4.6 MG/Day 24 HR Transdermal PatchSY82630f84-fb47-47ab-8ee2-1720a486de02108
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemSY82630f84-fb47-47ab-8ee2-1720a486de02108

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2065-16362920650130 POUCH in 1 CARTON (63629-2065-1) / 1 PATCH in 1 POUCH (63629-2065-2) / 24 h in 1 PATCH30 pouch2021-02-110000-00-00NoNoCurrent
63629-2065-2636292065021 in 1 POUCHHistorical