Exelon

Product NDC: 21695-357
11-digit product format: 216950357
Labeler code: 21695
Product ID: 21695-357_5d7c4d41-2df4-42d4-9a3d-0a567519bf2d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rivastigmine
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Rebel Distributors Corp
Application: NDA022083
Marketing category: NDA
Marketing start: 2009-10-07
Marketing end: 0000-00-00
Substance: RIVASTIGMINE
Active strength: 5 mg/24[USP'U]
Pharmacologic classes: Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	21695-357		I	Inactivated by FDA		2026-08-11
excluded package	package	21695-357	21695-357-30	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-357-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-357-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-357-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-357-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-357-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-357-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-357-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-357-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-357-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-357-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-357-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-357-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-357-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-357-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-357-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-357-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-357-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-357-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-357-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-357-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-357-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-357-30	`110d247fa046…`	`a55b01930146…`

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	RLD / RS	Approval date
N022083-001	EXELON	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06
N022083-002	EXELON	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06
N022083-005	EXELON	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022083-001	AB
N022083-002	AB
N022083-005	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022083-002	EXELON	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2007-07-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022083-005	EXELON	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2012-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022083-001	EXELON	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2007-07-06	`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	N022083-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022083-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022083-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022083-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022083-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022083-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022083-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022083-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022083-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022083-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022083-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022083-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022083-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022083-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022083-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022083-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022083-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022083-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022083-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022083-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022083-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022083-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022083-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022083-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022083-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022083-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022083-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022083-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022083-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022083-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022083-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022083-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022083-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022083-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022083-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022083-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022083-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022083-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022083-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022083-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022083-001	6316023	2019-01-08	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022083-001	6335031	2019-01-08	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022083-002	6316023	2019-01-08	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022083-002	6335031	2019-01-08	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022083-005	6316023	2019-01-08	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022083-005	6335031	2019-01-08	Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022083-001	6316023	2019-01-08	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022083-001	6335031	2019-01-08	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022083-002	6316023	2019-01-08	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022083-002	6335031	2019-01-08	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022083-005	6316023	2019-01-08	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022083-005	6335031	2019-01-08	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022083-001	6316023	2019-01-08	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022083-001	6335031	2019-01-08	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022083-002	6316023	2019-01-08	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022083-002	6335031	2019-01-08	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022083-005	6316023	2019-01-08	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022083-005	6335031	2019-01-08	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022083-001	6316023	2019-01-08	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022083-001	6335031	2019-01-08	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022083-002	6316023	2019-01-08	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022083-002	6335031	2019-01-08	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022083-005	6316023	2019-01-08	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022083-005	6335031	2019-01-08	Drug product	`ea99ee380514…`

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
21695-357-30	2019-09-24	C162847	48780-1	934fe258-4d2b-48b1-e053-8cdaa90a720a	Exelon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-357-30	Exelon	30 in 1 CARTON	PATCH, EXTENDED RELEASE	30		1
21695-357-30	Exelon	24 [USP'U] in 1 PATCH	PATCH, EXTENDED RELEASE	24		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-357-30	EA - Each	21695-357	7b6ccbd3-368d-4b87-9233-63bf08d2f9cb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RIVASTIGMINE	ACTIVE INGREDIENT	PKI06M3IW0	EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
RIVASTIGMINE	ACTIVE MOIETY	PKI06M3IW0	EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-357	EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20110103_5d7c4d41-2df4-42d4-9a3d-0a567519bf2d.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	Sandoz Inc	92a58ebb-748d-49f4-bf11-ecbcf5424152	2024-05-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022083 application number: NDA022083
Exelon	RIVASTIGMINE	Novartis Pharmaceuticals Corporation	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	2024-05-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022083 application number: NDA022083
Exelon	RIVASTIGMINE	Sandoz Inc	b6ed6d15-116d-4596-92ce-3414574d7ba0	2024-05-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022083 application number: NDA022083

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
751302	EXELON PATCH 4.6 MG/DAY 24HR Transdermal System	PSN	5d7c4d41-2df4-42d4-9a3d-0a567519bf2d	1
725021	rivastigmine 4.6 MG/Day 24HR Transdermal System	PSN	5d7c4d41-2df4-42d4-9a3d-0a567519bf2d	1
751302	24 HR rivastigmine 0.192 MG/HR Transdermal System [Exelon]	SBD	5d7c4d41-2df4-42d4-9a3d-0a567519bf2d	1
725021	24 HR rivastigmine 0.192 MG/HR Transdermal System	SCD	5d7c4d41-2df4-42d4-9a3d-0a567519bf2d	1
751302	24 HR Exelon 0.192 MG/HR Transdermal System	SY	5d7c4d41-2df4-42d4-9a3d-0a567519bf2d	1
751302	Exelon 0.192 MG/HR 24HR Transdermal Patch	SY	5d7c4d41-2df4-42d4-9a3d-0a567519bf2d	1
751302	Exelon 4.6 MG per 24HR 1 Day Transdermal Patch	SY	5d7c4d41-2df4-42d4-9a3d-0a567519bf2d	1
751302	EXELON PATCH 4.6 MG/DAY 24HR Transdermal System	SY	5d7c4d41-2df4-42d4-9a3d-0a567519bf2d	1
725021	rivastigmine 0.192 MG/HR 24 HR Transdermal Patch	SY	5d7c4d41-2df4-42d4-9a3d-0a567519bf2d	1
725021	rivastigmine 4.6 MG/Day 24 HR Transdermal Patch	SY	5d7c4d41-2df4-42d4-9a3d-0a567519bf2d	1
725021	rivastigmine 4.6 MG/Day 24HR Transdermal System	SY	5d7c4d41-2df4-42d4-9a3d-0a567519bf2d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-357-30	21695035730	30 in 1 CARTON	Historical