Rivastigmine

Manufacturer: Zydus Lifesciences Limited
Effective date: 2025-11-17
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 21:46:07

Label at a glance#

ProductRivastigmine

Active ingredientRIVASTIGMINE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx only

NDC 70771-1949-7

Rivastigmine

Transdermal System

Each System Delivers 4.6 mg/24 hours

For Transdermal Use Only.

Contains 30 systems

Rx only

NDC 70771-1950-7

Rivastigmine

Transdermal System

Each System Delivers 9.5 mg/24 hours

For Transdermal Use Only.

Contains 30 systems

Rx only

NDC 70771-1951-7

Rivastigmine

Transdermal System

Each System Delivers 13.3 mg/24 hours

For Transdermal Use Only.

Contains 30 systems

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1308569	rivastigmine 13.3 MG/Day 24HR Transdermal System	PSN	1
725021	rivastigmine 4.6 MG/Day 24HR Transdermal System	PSN	1
725023	rivastigmine 9.5 MG/Day 24HR Transdermal System	PSN	1
725021	24 HR rivastigmine 0.192 MG/HR Transdermal System	SCD	1
725023	24 HR rivastigmine 0.396 MG/HR Transdermal System	SCD	1
1308569	24 HR rivastigmine 0.554 MG/HR Transdermal System	SCD	1
725021	rivastigmine 0.192 MG/HR 24 HR Transdermal Patch	SY	1
725023	rivastigmine 0.396 MG/HR 24 HR Transdermal Patch	SY	1
1308569	rivastigmine 13.3 MG/Day 24HR Transdermal Patch	SY	1
1308569	rivastigmine 13.3 MG/Day 24HR Transdermal System	SY	1
725021	rivastigmine 4.6 MG/Day 24 HR Transdermal Patch	SY	1
725021	rivastigmine 4.6 MG/Day 24HR Transdermal System	SY	1
725023	rivastigmine 9.5 MG/Day 24 HR Transdermal Patch	SY	1
725023	rivastigmine 9.5 MG/Day 24HR Transdermal System	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
RIVASTIGMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20220119

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
70771-1949-1	Rivastigmine	24 h in 1 POUCH	PATCH, EXTENDED RELEASE	24	1
70771-1949-7	Rivastigmine	30 in 1 CARTON	PATCH, EXTENDED RELEASE	30	1
70771-1950-1	Rivastigmine	24 h in 1 POUCH	PATCH, EXTENDED RELEASE	24	1
70771-1950-7	Rivastigmine	30 in 1 CARTON	PATCH, EXTENDED RELEASE	30	1
70771-1951-1	Rivastigmine	24 h in 1 POUCH	PATCH, EXTENDED RELEASE	24	1
70771-1951-7	Rivastigmine	30 in 1 CARTON	PATCH, EXTENDED RELEASE	30	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

Rivastigmine
SILICON DIOXIDE
LIGHT MINERAL OIL
POLYISOBUTYLENE (1100000 MW)
POLYISOBUTYLENE (55000 MW)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1949	70771-1949-1, 70771-1949-7
70771-1950	70771-1950-1, 70771-1950-7
70771-1951	70771-1951-1, 70771-1951-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
RIVASTIGMINE	PKI06M3IW0	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
POLYISOBUTYLENE (1100000 MW)	FLT10CH37X	IACT
POLYISOBUTYLENE (55000 MW)	TQ77WR8A02	IACT
RIVASTIGMINE	PKI06M3IW0	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
POLYISOBUTYLENE (1100000 MW)	FLT10CH37X	IACT
POLYISOBUTYLENE (55000 MW)	TQ77WR8A02	IACT
RIVASTIGMINE	PKI06M3IW0	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
POLYISOBUTYLENE (1100000 MW)	FLT10CH37X	IACT
POLYISOBUTYLENE (55000 MW)	TQ77WR8A02	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
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 · 129 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	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A206318-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206318-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206318-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206318-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206318-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206318-003	AB	1	`caaa826d4ba7…`
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…`

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 · 1 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 ndc (package): 70771-1949-1 ndc (package): 70771-1950-1 ndc (package): 70771-1950-7 ndc (package): 70771-1949-7 ndc (package): 70771-1951-1 ndc (package): 70771-1951-7 ndc (product): 70771-1951 ndc (product): 70771-1950 ndc (product): 70771-1949 ndc11 (package): 70771195101 ndc11 (package): 70771195001 ndc11 (package): 70771194907 ndc11 (package): 70771195107 ndc11 (package): 70771195007 ndc11 (package): 70771194901 spl id: eb52b342-1672-42e7-bb4c-9c8f1bce7fc3 spl set id: 966d59ea-5cea-4fef-8b96-e0efe885caf4

Reported adverse events (FAERS/openFDA)#

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