Rivastigmine

Product NDC: 51956-0003
11-digit product format: 519560003
Labeler code: 51956
Product ID: 51956-0003_8ce6f8ae-c5f5-4731-8efb-9a8c3d52942f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rivastigmine
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Zydus Lifesciences Limited
Application: ANDA206318
Marketing category: ANDA
Marketing start: 2019-03-06
Marketing end: 0000-00-00
Substance: RIVASTIGMINE
Active strength: 13 mg/24h
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51956-0003		I	Inactivated by FDA		2026-08-11
excluded package	package	51956-0003	51956-0003-7	I	Inactivated by FDA		2026-08-11

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206318-001	RIVASTIGMINE	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04
A206318-002	RIVASTIGMINE	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04
A206318-003	RIVASTIGMINE	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206318-001	AB
A206318-002	AB
A206318-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206318-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206318-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206318-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206318-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206318-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206318-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206318-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206318-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206318-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206318-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206318-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206318-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206318-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206318-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206318-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206318-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206318-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206318-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206318-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206318-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206318-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206318-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206318-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206318-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206318-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206318-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206318-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206318-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206318-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206318-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206318-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206318-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206318-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206318-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206318-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206318-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206318-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206318-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206318-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206318-001	AB	1	`8072bd15b7f6…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51956-0003-7	2026-01-29	C162847	48780-1	49896155-c1d0-586f-e063-e6dba90add90	These highlights do not include all the information needed to use RIVASTIGMINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for RIVASTIGMINE TRANSDERMAL SYSTEM. Rivastigmine Transdermal System Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51956-0003-1	Rivastigmine	24 h in 1 POUCH	PATCH, EXTENDED RELEASE	24		3
51956-0003-7	Rivastigmine	30 in 1 CARTON	PATCH, EXTENDED RELEASE	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51956-0003	RIVASTIGMINE PATCH, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]	3	Legacy NDC, 2 package rows	20221007_7d8414f5-b51f-4ccb-b7a1-83b9ede5b266.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rivastigmine	RIVASTIGMINE	Zydus Lifesciences Limited	966d59ea-5cea-4fef-8b96-e0efe885caf4	2025-11-17		Exact identifier application applno (ANDA): 206318 application number: ANDA206318
Rivastigmine	RIVASTIGMINE	Northstar Rx LLC.	8b809739-8381-4cc1-ab4a-5b17ab902a3d	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206318 application number: ANDA206318
Rivastigmine	RIVASTIGMINE	Zydus Pharmaceuticals USA Inc.	64dad603-2389-456b-8c18-d1d40b7e7419	2024-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206318 application number: ANDA206318

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	7d8414f5-b51f-4ccb-b7a1-83b9ede5b266	3
725021	rivastigmine 4.6 MG/Day 24HR Transdermal System	PSN	7d8414f5-b51f-4ccb-b7a1-83b9ede5b266	3
725023	rivastigmine 9.5 MG/Day 24HR Transdermal System	PSN	7d8414f5-b51f-4ccb-b7a1-83b9ede5b266	3
725021	24 HR rivastigmine 0.192 MG/HR Transdermal System	SCD	7d8414f5-b51f-4ccb-b7a1-83b9ede5b266	3
725023	24 HR rivastigmine 0.396 MG/HR Transdermal System	SCD	7d8414f5-b51f-4ccb-b7a1-83b9ede5b266	3
1308569	24 HR rivastigmine 0.554 MG/HR Transdermal System	SCD	7d8414f5-b51f-4ccb-b7a1-83b9ede5b266	3
725021	rivastigmine 0.192 MG/HR 24 HR Transdermal Patch	SY	7d8414f5-b51f-4ccb-b7a1-83b9ede5b266	3
725023	rivastigmine 0.396 MG/HR 24 HR Transdermal Patch	SY	7d8414f5-b51f-4ccb-b7a1-83b9ede5b266	3
1308569	rivastigmine 13.3 MG/Day 24HR Transdermal Patch	SY	7d8414f5-b51f-4ccb-b7a1-83b9ede5b266	3
1308569	rivastigmine 13.3 MG/Day 24HR Transdermal System	SY	7d8414f5-b51f-4ccb-b7a1-83b9ede5b266	3
725021	rivastigmine 4.6 MG/Day 24 HR Transdermal Patch	SY	7d8414f5-b51f-4ccb-b7a1-83b9ede5b266	3
725021	rivastigmine 4.6 MG/Day 24HR Transdermal System	SY	7d8414f5-b51f-4ccb-b7a1-83b9ede5b266	3
725023	rivastigmine 9.5 MG/Day 24 HR Transdermal Patch	SY	7d8414f5-b51f-4ccb-b7a1-83b9ede5b266	3
725023	rivastigmine 9.5 MG/Day 24HR Transdermal System	SY	7d8414f5-b51f-4ccb-b7a1-83b9ede5b266	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51956-0003-1	51956000301	24 h in 1 POUCH	24 h					Historical
51956-0003-7	51956000307	30 POUCH in 1 CARTON (51956-0003-7) > 24 h in 1 POUCH (51956-0003-1)	30 pouch	2019-03-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rivastigmine - Zydus Lifesciences Limited	Zydus Lifesciences Limited	2022-10-04	HUMAN PRESCRIPTION DRUG LABEL	3