FDA.reportPublic FDA data

Rivastigmine Transdermal System

Product NDC
63629-8807
11-digit product format
636298807
Labeler code
63629
Product ID
63629-8807_728327eb-6899-4802-a7f2-a68bb7c97c3e
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
9.5 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
RIVASTIGMINE9.5 mg/24h

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPKI06M3IW0
Rxcui725023

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
63629-8807-1Rivastigmine Transdermal System30 in 1 CARTONPATCH, EXTENDED RELEASE30110
63629-8807-2Rivastigmine Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE1110
63629-8807-2Rivastigmine Transdermal System24 h in 1 PATCHPATCH, EXTENDED RELEASE24110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8807-1EA - Each63629-8807ce941c9c-f4e1-4eea-8544-17448d3643ce12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8807RIVASTIGMINE TRANSDERMAL SYSTEM (RIVASTIGMINE) PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]110Current NDC, Legacy NDC, 3 package rows20250115_c569f760-f311-42ba-909c-a36319622b35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
725023rivastigmine 9.5 MG/Day 24HR Transdermal SystemPSNc569f760-f311-42ba-909c-a36319622b35110
72502324 HR rivastigmine 0.396 MG/HR Transdermal SystemSCDc569f760-f311-42ba-909c-a36319622b35110
725023rivastigmine 0.396 MG/HR 24 HR Transdermal PatchSYc569f760-f311-42ba-909c-a36319622b35110
725023rivastigmine 9.5 MG/Day 24 HR Transdermal PatchSYc569f760-f311-42ba-909c-a36319622b35110
725023rivastigmine 9.5 MG/Day 24HR Transdermal SystemSYc569f760-f311-42ba-909c-a36319622b35110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8807-16362988070130 POUCH in 1 CARTON (63629-8807-1) / 1 PATCH in 1 POUCH (63629-8807-2) / 24 h in 1 PATCH30 pouch2021-09-010000-00-00NoNoCurrent
63629-8807-2636298807021 in 1 POUCHHistorical