Exelon

Product NDC: 0078-0502
11-digit product format: 000780502
Labeler code: 0078
Product ID: 0078-0502_9b5555ca-d9a2-4f50-8037-abbf702d0a27
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rivastigmine
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA022083
Marketing category: NDA
Marketing start: 2007-07-06
Marketing end: 2026-12-31
Substance: RIVASTIGMINE
Active strength: 9.5 mg/24h
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag: No
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-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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Exelon

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RIVASTIGMINE	9.5 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
725021	Internal RxNorm lookup
725023	Internal RxNorm lookup
725105	Internal RxNorm lookup
751302	Internal RxNorm lookup
1308569	Internal RxNorm lookup
1308571	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
07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	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	Strength	SPL version
0078-0502-15	Exelon	30 in 1 CARTON	PATCH, EXTENDED RELEASE	30		30
0078-0502-61	Exelon	24 h in 1 PATCH	PATCH, EXTENDED RELEASE	24		30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0502-15	EA - Each	0078-0502	976ff0bf-0340-4a4c-9943-9129cb1dd22e	1	2012-07-24
0078-0502-61	EA - Each	0078-0502	c313127f-8dd4-42eb-9d43-9c0e944ba345	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 [NOVARTIS PHARMACEUTICALS CORPORATION]	16
RIVASTIGMINE	ACTIVE MOIETY	PKI06M3IW0	EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	16
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	16
RIVASTIGMINE	ACTIVE INGREDIENT	PKI06M3IW0	EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
RIVASTIGMINE	ACTIVE MOIETY	PKI06M3IW0	EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0502	EXELON (RIVASTIGMINE) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]	29	Current NDC, Legacy NDC, 2 package rows	20240517_07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0.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 ndc (product): 0078-0502
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
1308571	EXELON PATCH 13.3 MG/Day 24HR Transdermal System	PSN	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
751302	EXELON PATCH 4.6 MG/DAY 24HR Transdermal System	PSN	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725105	EXELON PATCH 9.5 MG/Day 24HR Transdermal System	PSN	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
1308569	rivastigmine 13.3 MG/Day 24HR Transdermal System	PSN	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725021	rivastigmine 4.6 MG/Day 24HR Transdermal System	PSN	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725023	rivastigmine 9.5 MG/Day 24HR Transdermal System	PSN	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
751302	24 HR rivastigmine 0.192 MG/HR Transdermal System [Exelon]	SBD	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725105	24 HR rivastigmine 0.396 MG/HR Transdermal System [Exelon]	SBD	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
1308571	24 HR rivastigmine 0.554 MG/HR Transdermal System [Exelon]	SBD	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725021	24 HR rivastigmine 0.192 MG/HR Transdermal System	SCD	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725023	24 HR rivastigmine 0.396 MG/HR Transdermal System	SCD	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
1308569	24 HR rivastigmine 0.554 MG/HR Transdermal System	SCD	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
751302	24 HR Exelon 0.192 MG/HR Transdermal System	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725105	24 HR Exelon 0.396 MG/HR Transdermal System	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
1308571	24 HR Exelon 0.554 MG/HR Transdermal System	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
751302	Exelon 0.192 MG/HR 24HR Transdermal Patch	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725105	Exelon 0.396 MG/HR 24 HR Transdermal Patch	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
1308571	Exelon 13.3 MG per 24HR 1 Day Transdermal Patch	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
751302	Exelon 4.6 MG per 24HR 1 Day Transdermal Patch	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725105	Exelon 9.5 MG/Day 24 HR Transdermal Patch	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
1308571	EXELON PATCH 13.3 MG/Day 24HR Transdermal System	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
751302	EXELON PATCH 4.6 MG/DAY 24HR Transdermal System	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725105	EXELON PATCH 9.5 MG/Day 24HR Transdermal System	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725021	rivastigmine 0.192 MG/HR 24 HR Transdermal Patch	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725023	rivastigmine 0.396 MG/HR 24 HR Transdermal Patch	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
1308569	rivastigmine 13.3 MG/Day 24HR Transdermal Patch	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
1308569	rivastigmine 13.3 MG/Day 24HR Transdermal System	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725021	rivastigmine 4.6 MG/Day 24 HR Transdermal Patch	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725021	rivastigmine 4.6 MG/Day 24HR Transdermal System	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725023	rivastigmine 9.5 MG/Day 24 HR Transdermal Patch	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
725023	rivastigmine 9.5 MG/Day 24HR Transdermal System	SY	07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0	30
751302	EXELON PATCH 4.6 MG/DAY 24HR Transdermal System	PSN	29481887-34eb-460a-bd7f-b8755473065a	2
725105	EXELON PATCH 9.5 MG/Day 24HR Transdermal System	PSN	29481887-34eb-460a-bd7f-b8755473065a	2
725021	rivastigmine 4.6 MG/Day 24HR Transdermal System	PSN	29481887-34eb-460a-bd7f-b8755473065a	2
725023	rivastigmine 9.5 MG/Day 24HR Transdermal System	PSN	29481887-34eb-460a-bd7f-b8755473065a	2
751302	24 HR rivastigmine 0.192 MG/HR Transdermal System [Exelon]	SBD	29481887-34eb-460a-bd7f-b8755473065a	2
725105	24 HR rivastigmine 0.396 MG/HR Transdermal System [Exelon]	SBD	29481887-34eb-460a-bd7f-b8755473065a	2
725021	24 HR rivastigmine 0.192 MG/HR Transdermal System	SCD	29481887-34eb-460a-bd7f-b8755473065a	2
725023	24 HR rivastigmine 0.396 MG/HR Transdermal System	SCD	29481887-34eb-460a-bd7f-b8755473065a	2
751302	24 HR Exelon 0.192 MG/HR Transdermal System	SY	29481887-34eb-460a-bd7f-b8755473065a	2
725105	24 HR Exelon 0.396 MG/HR Transdermal System	SY	29481887-34eb-460a-bd7f-b8755473065a	2
751302	Exelon 0.192 MG/HR 24HR Transdermal Patch	SY	29481887-34eb-460a-bd7f-b8755473065a	2
725105	Exelon 0.396 MG/HR 24 HR Transdermal Patch	SY	29481887-34eb-460a-bd7f-b8755473065a	2
751302	Exelon 4.6 MG per 24HR 1 Day Transdermal Patch	SY	29481887-34eb-460a-bd7f-b8755473065a	2
725105	Exelon 9.5 MG/Day 24 HR Transdermal Patch	SY	29481887-34eb-460a-bd7f-b8755473065a	2
751302	EXELON PATCH 4.6 MG/DAY 24HR Transdermal System	SY	29481887-34eb-460a-bd7f-b8755473065a	2
725105	EXELON PATCH 9.5 MG/Day 24HR Transdermal System	SY	29481887-34eb-460a-bd7f-b8755473065a	2
725021	rivastigmine 0.192 MG/HR 24 HR Transdermal Patch	SY	29481887-34eb-460a-bd7f-b8755473065a	2
725023	rivastigmine 0.396 MG/HR 24 HR Transdermal Patch	SY	29481887-34eb-460a-bd7f-b8755473065a	2
725021	rivastigmine 4.6 MG/Day 24 HR Transdermal Patch	SY	29481887-34eb-460a-bd7f-b8755473065a	2
725021	rivastigmine 4.6 MG/Day 24HR Transdermal System	SY	29481887-34eb-460a-bd7f-b8755473065a	2
725023	rivastigmine 9.5 MG/Day 24 HR Transdermal Patch	SY	29481887-34eb-460a-bd7f-b8755473065a	2
725023	rivastigmine 9.5 MG/Day 24HR Transdermal System	SY	29481887-34eb-460a-bd7f-b8755473065a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0502-15	00078050215	30 PATCH in 1 CARTON (0078-0502-15) / 24 h in 1 PATCH (0078-0502-61)	30 patch	2007-07-06	2026-12-31	No	No	Current
0078-0502-61	00078050261	24 h in 1 PATCH	24 h					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Exelon	Novartis Pharmaceuticals Corporation	2024-05-08	HUMAN PRESCRIPTION DRUG LABEL	30
Exelon - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-02-22	HUMAN PRESCRIPTION DRUG LABEL	2