FDA.reportPublic FDA data

Rivastigmine Transdermal System

Product NDC
51991-897
11-digit product format
519910897
Labeler code
51991
Product ID
51991-897_6c0c606b-108e-4837-8533-f485f9e4ee4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivastigmine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Breckenridge Pharmaceutical, Inc.
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, 725023, 1308569

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
51991-897-30Rivastigmine Transdermal System30 in 1 CARTONPATCH, EXTENDED RELEASE307
51991-897-99Rivastigmine Transdermal System24 h in 1 PATCHPATCH, EXTENDED RELEASE247
51991-897-99Rivastigmine Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-897-30EA - Each51991-8974a984fdf-be09-4cfa-8adc-ae28519473ff12020-02-13
51991-897-99EA - Each51991-89763fe4399-495d-467d-afc5-8a08d0fcbe0612020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-897RIVASTIGMINE TRANSDERMAL SYSTEM (RIVASTIGMINE) PATCH, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]7Current NDC, Legacy NDC, 3 package rows20250119_b201fe68-b5e5-4a6f-8cf1-069543f03e76.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
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
1308569rivastigmine 13.3 MG/Day 24HR Transdermal SystemPSNb201fe68-b5e5-4a6f-8cf1-069543f03e767
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemPSNb201fe68-b5e5-4a6f-8cf1-069543f03e767
725023rivastigmine 9.5 MG/Day 24HR Transdermal SystemPSNb201fe68-b5e5-4a6f-8cf1-069543f03e767
72502124 HR rivastigmine 0.192 MG/HR Transdermal SystemSCDb201fe68-b5e5-4a6f-8cf1-069543f03e767
72502324 HR rivastigmine 0.396 MG/HR Transdermal SystemSCDb201fe68-b5e5-4a6f-8cf1-069543f03e767
130856924 HR rivastigmine 0.554 MG/HR Transdermal SystemSCDb201fe68-b5e5-4a6f-8cf1-069543f03e767
725021rivastigmine 0.192 MG/HR 24 HR Transdermal PatchSYb201fe68-b5e5-4a6f-8cf1-069543f03e767
725023rivastigmine 0.396 MG/HR 24 HR Transdermal PatchSYb201fe68-b5e5-4a6f-8cf1-069543f03e767
1308569rivastigmine 13.3 MG/Day 24HR Transdermal PatchSYb201fe68-b5e5-4a6f-8cf1-069543f03e767
1308569rivastigmine 13.3 MG/Day 24HR Transdermal SystemSYb201fe68-b5e5-4a6f-8cf1-069543f03e767
725021rivastigmine 4.6 MG/Day 24 HR Transdermal PatchSYb201fe68-b5e5-4a6f-8cf1-069543f03e767
725021rivastigmine 4.6 MG/Day 24HR Transdermal SystemSYb201fe68-b5e5-4a6f-8cf1-069543f03e767
725023rivastigmine 9.5 MG/Day 24 HR Transdermal PatchSYb201fe68-b5e5-4a6f-8cf1-069543f03e767
725023rivastigmine 9.5 MG/Day 24HR Transdermal SystemSYb201fe68-b5e5-4a6f-8cf1-069543f03e767

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-897-305199108973030 POUCH in 1 CARTON (51991-897-30) / 1 PATCH in 1 POUCH (51991-897-99) / 24 h in 1 PATCH30 pouch2019-12-190000-00-00NoNoCurrent
51991-897-995199108979924 h in 1 PATCH24 hHistorical