FDA.reportPublic FDA data

Rivastigmine Transdermal System

Product NDC
72162-1610
11-digit product format
721621610
Labeler code
72162
Product ID
72162-1610_4ad5e43c-1d8c-46b6-a99c-a46d60a8f264
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
72162-1610-3Rivastigmine Transdermal System30 in 1 CARTONPATCH, EXTENDED RELEASE30102
72162-1610-3Rivastigmine Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE1102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1610-3EA - Each72162-161049db76a3-6976-4ff8-8709-ba590c3076c112025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1610RIVASTIGMINE TRANSDERMAL SYSTEM (RIVASTIGMINE) PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20250403_8d8823c0-9339-4ec8-8a19-d13974b6614b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1308569rivastigmine 13.3 MG/Day 24HR Transdermal SystemPSN8d8823c0-9339-4ec8-8a19-d13974b6614b102
130856924 HR rivastigmine 0.554 MG/HR Transdermal SystemSCD8d8823c0-9339-4ec8-8a19-d13974b6614b102
1308569rivastigmine 13.3 MG/Day 24HR Transdermal PatchSY8d8823c0-9339-4ec8-8a19-d13974b6614b102
1308569rivastigmine 13.3 MG/Day 24HR Transdermal SystemSY8d8823c0-9339-4ec8-8a19-d13974b6614b102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1610-37216216100330 POUCH in 1 CARTON (72162-1610-3) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH30 pouch2024-12-24NoNoHistorical