FDA.reportPublic FDA data

Rivastigmine Transdermal System

Product NDC
63629-8846
11-digit product format
636298846
Labeler code
63629
Product ID
63629-8846_7dd9ff5a-6b39-4c61-88aa-dc7f97900a91
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
13.3 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
RIVASTIGMINE13.3 mg/24h

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPKI06M3IW0
Rxcui1308569

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
63629-8846-1Rivastigmine Transdermal System30 in 1 CARTONPATCH, EXTENDED RELEASE30111
63629-8846-2Rivastigmine Transdermal System24 h in 1 PATCHPATCH, EXTENDED RELEASE24111
63629-8846-2Rivastigmine Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE1111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8846-1EA - Each63629-884690d20370-a07c-42a1-b19e-fb5d9ad62f8112021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8846RIVASTIGMINE TRANSDERMAL SYSTEM (RIVASTIGMINE) PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]111Current NDC, Legacy NDC, 3 package rows20250330_5cd5c434-ffd0-4aed-9eba-145c86b115bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1308569rivastigmine 13.3 MG/Day 24HR Transdermal SystemPSN5cd5c434-ffd0-4aed-9eba-145c86b115bb111
130856924 HR rivastigmine 0.554 MG/HR Transdermal SystemSCD5cd5c434-ffd0-4aed-9eba-145c86b115bb111
1308569rivastigmine 13.3 MG/Day 24HR Transdermal PatchSY5cd5c434-ffd0-4aed-9eba-145c86b115bb111
1308569rivastigmine 13.3 MG/Day 24HR Transdermal SystemSY5cd5c434-ffd0-4aed-9eba-145c86b115bb111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8846-16362988460130 POUCH in 1 CARTON (63629-8846-1) / 1 PATCH in 1 POUCH (63629-8846-2) / 24 h in 1 PATCH30 pouch2021-09-200000-00-00NoNoCurrent
63629-8846-26362988460224 h in 1 PATCH24 hHistorical