Rivastigmine Transdermal System

Product NDC
63629-2065
11-digit product format
636292065
Labeler code
63629
Product ID
63629-2065_514cd09f-04ed-46b0-8d34-802d6c0d969d
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209063-001RIVASTIGMINERIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26
A209063-002RIVASTIGMINERIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26
A209063-003RIVASTIGMINERIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A209063-001AB
A209063-002AB
A209063-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209063-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209063-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209063-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209063-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209063-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209063-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209063-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209063-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209063-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209063-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209063-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209063-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209063-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209063-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209063-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209063-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209063-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209063-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209063-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209063-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209063-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209063-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209063-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209063-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209063-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209063-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209063-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209063-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209063-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209063-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209063-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209063-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209063-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209063-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209063-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209063-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209063-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209063-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209063-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209063-001AB18072bd15b7f6…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PKI06M3IW0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
725021Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
82630f84-fb47-47ab-8ee2-1720a486de02Available on FDA.report

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
63629-2065-1Rivastigmine Transdermal System30 in 1 CARTONPATCH, EXTENDED RELEASE30108
63629-2065-2Rivastigmine Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE1108
63629-2065-2Rivastigmine Transdermal System24 h in 1 PATCHPATCH, EXTENDED RELEASE24108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2065-1EA - Each63629-20654286a6bb-9a74-46e3-8838-3882d256194812021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2065RIVASTIGMINE TRANSDERMAL SYSTEM (RIVASTIGMINE) PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]108Current NDC, Legacy NDC, 3 package rows20240820_82630f84-fb47-47ab-8ee2-1720a486de02.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack8d8823c0-9339-4ec8-8a19-d13974b6614b2025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepacka7f9328e-b6da-4474-ac93-3cdd4825e1632025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack5cd5c434-ffd0-4aed-9eba-145c86b115bb2025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepacka68d70c9-19f2-47db-bf78-4da04a87a7022025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack6cc286d9-c5d4-4505-83bb-9015e30778512025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
Rivastigmine Transdermal SystemRIVASTIGMINEBreckenridge Pharmaceutical, Inc.b201fe68-b5e5-4a6f-8cf1-069543f03e762025-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack1ebeb8ec-5348-4bb1-ab3d-8346903510942024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack82630f84-fb47-47ab-8ee2-1720a486de022024-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
ndc (product): 63629-2065
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepackc569f760-f311-42ba-909c-a36319622b352024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2065-16362920650130 POUCH in 1 CARTON (63629-2065-1) / 1 PATCH in 1 POUCH (63629-2065-2) / 24 h in 1 PATCH30 pouch2021-02-110000-00-00NoNoCurrent
63629-2065-2636292065021 in 1 POUCHHistorical