Rivastigmine Transdermal System

Product NDC: 63629-8846
Requested package NDC: 63629-8846-1
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209063-001	RIVASTIGMINE	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26
A209063-002	RIVASTIGMINE	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26
A209063-003	RIVASTIGMINE	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26

Therapeutic equivalence codes#

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

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

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 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209063-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209063-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209063-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209063-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209063-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209063-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209063-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209063-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209063-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209063-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209063-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209063-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209063-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209063-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209063-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209063-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209063-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209063-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209063-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209063-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209063-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209063-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209063-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209063-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209063-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209063-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209063-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209063-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209063-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209063-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209063-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209063-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209063-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209063-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209063-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209063-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209063-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209063-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209063-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209063-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-11-26	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209063-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209063-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209063-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209063-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209063-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209063-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209063-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209063-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209063-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209063-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209063-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209063-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209063-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209063-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209063-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209063-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209063-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209063-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209063-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209063-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209063-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209063-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209063-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209063-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209063-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209063-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209063-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209063-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209063-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209063-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209063-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209063-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209063-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209063-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209063-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209063-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209063-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209063-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209063-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209063-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Rivastigmine Transdermal System
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RIVASTIGMINE	13.3 mg/24h

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PKI06M3IW0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1308569	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
5cd5c434-ffd0-4aed-9eba-145c86b115bb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f5a24cc0-a293-4838-b663-7e454a66c2c3	Product name	5	20200513
64bcf1db-afe4-78b0-8e9c-f7cb25e1b791	Product name	6	20171121

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-8846-1	Rivastigmine Transdermal System	30 in 1 CARTON	PATCH, EXTENDED RELEASE	30	111
63629-8846-2	Rivastigmine Transdermal System	24 h in 1 PATCH	PATCH, EXTENDED RELEASE	24	111
63629-8846-2	Rivastigmine Transdermal System	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1	111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8846-1	EA - Each	63629-8846	90d20370-a07c-42a1-b19e-fb5d9ad62f81	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8846	RIVASTIGMINE TRANSDERMAL SYSTEM (RIVASTIGMINE) PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]	111	Current NDC, Legacy NDC, 3 package rows	20250330_5cd5c434-ffd0-4aed-9eba-145c86b115bb.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	8d8823c0-9339-4ec8-8a19-d13974b6614b	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209063 application number: ANDA209063
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	a7f9328e-b6da-4474-ac93-3cdd4825e163	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209063 application number: ANDA209063
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	5cd5c434-ffd0-4aed-9eba-145c86b115bb	2025-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209063 application number: ANDA209063 ndc (package): 63629-8846-1 ndc (product): 63629-8846 ndc11 (package): 63629884601
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	a68d70c9-19f2-47db-bf78-4da04a87a702	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209063 application number: ANDA209063
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	6cc286d9-c5d4-4505-83bb-9015e3077851	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209063 application number: ANDA209063
Rivastigmine Transdermal System	RIVASTIGMINE	Breckenridge Pharmaceutical, Inc.	b201fe68-b5e5-4a6f-8cf1-069543f03e76	2025-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209063 application number: ANDA209063
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	1ebeb8ec-5348-4bb1-ab3d-834690351094	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209063 application number: ANDA209063
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	82630f84-fb47-47ab-8ee2-1720a486de02	2024-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209063 application number: ANDA209063
Rivastigmine Transdermal System	RIVASTIGMINE	Bryant Ranch Prepack	c569f760-f311-42ba-909c-a36319622b35	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209063 application number: ANDA209063

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PKI06M3IW0	RIVASTIGMINE	123441-03-2	RIVASTIGMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1308569	rivastigmine 13.3 MG/Day 24HR Transdermal System	PSN	5cd5c434-ffd0-4aed-9eba-145c86b115bb	111
1308569	24 HR rivastigmine 0.554 MG/HR Transdermal System	SCD	5cd5c434-ffd0-4aed-9eba-145c86b115bb	111
1308569	rivastigmine 13.3 MG/Day 24HR Transdermal Patch	SY	5cd5c434-ffd0-4aed-9eba-145c86b115bb	111
1308569	rivastigmine 13.3 MG/Day 24HR Transdermal System	SY	5cd5c434-ffd0-4aed-9eba-145c86b115bb	111

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8846-1	63629884601	30 POUCH in 1 CARTON (63629-8846-1) / 1 PATCH in 1 POUCH (63629-8846-2) / 24 h in 1 PATCH	30 pouch	2021-09-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rivastigmine Transdermal System - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-03-27	HUMAN PRESCRIPTION DRUG LABEL	111