FDA.reportPublic FDA data

Rivastigmine Transdermal System

Product NDC
72162-1608
11-digit product format
721621608
Labeler code
72162
Product ID
72162-1608_81f46b58-47d0-4178-a683-2a6c962c347b
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
72162-1608-3Rivastigmine Transdermal System30 in 1 CARTONPATCH, EXTENDED RELEASE30102
72162-1608-4Rivastigmine Transdermal System24 h in 1 PATCHPATCH, EXTENDED RELEASE24102
72162-1608-4Rivastigmine Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE1102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1608-3EA - Each72162-16087d1a9854-3a0f-4784-abe3-e221e68b93f712023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1608RIVASTIGMINE TRANSDERMAL SYSTEM (RIVASTIGMINE) PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, 3 package rows20250403_a7f9328e-b6da-4474-ac93-3cdd4825e163.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemPSNa7f9328e-b6da-4474-ac93-3cdd4825e163102
72502124 HR rivastigmine 0.192 MG/HR Transdermal SystemSCDa7f9328e-b6da-4474-ac93-3cdd4825e163102
725021rivastigmine 0.192 MG/HR 24 HR Transdermal PatchSYa7f9328e-b6da-4474-ac93-3cdd4825e163102
725021rivastigmine 4.6 MG/Day 24 HR Transdermal PatchSYa7f9328e-b6da-4474-ac93-3cdd4825e163102
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemSYa7f9328e-b6da-4474-ac93-3cdd4825e163102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1608-37216216080330 POUCH in 1 CARTON (72162-1608-3) / 1 PATCH in 1 POUCH (72162-1608-4) / 24 h in 1 PATCH30 pouch2019-12-19NoNoHistorical
72162-1608-47216216080424 h in 1 PATCH24 hHistorical