Rasagiline

Product NDC: 70518-4683
11-digit product format: 705184683
Labeler code: 70518
Product ID: 70518-4683_552be683-7db9-83c6-e063-6294a90a1883
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rasagiline
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA201889
Marketing category: ANDA
Marketing start: 2026-06-26
Substance: RASAGILINE MESYLATE
Active strength: .5 mg/1
Pharmacologic classes: Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201889-001	RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB		2017-10-30
A201889-002	RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB		2017-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A201889-001	AB
A201889-002	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 · 86 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	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201889-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-10-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201889-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-10-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A201889-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201889-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201889-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201889-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201889-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201889-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201889-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201889-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201889-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201889-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201889-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201889-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201889-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201889-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201889-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201889-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201889-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201889-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201889-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201889-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201889-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201889-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201889-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201889-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201889-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201889-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201889-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201889-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201889-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201889-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201889-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201889-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201889-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201889-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201889-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201889-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201889-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201889-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201889-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201889-002	AB	1	`74a2ff9319b5…`

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: Rasagiline
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RASAGILINE MESYLATE	.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LH8C2JI290	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
636664	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
fdebcedc-1b5e-4803-9617-58d705cda726	Available on FDA.report

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rasagiline	RASAGILINE	REMEDYREPACK INC.	9bf059f4-4da8-48fe-aacb-c50717d36606	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201889 application number: ANDA201889
Rasagiline	RASAGILINE	Ascend Laboratories, LLC	5dfeec8f-f4f3-4e06-915e-3244467516a6	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201889 application number: ANDA201889
Rasagiline	RASAGILINE	REMEDYREPACK INC.	fdebcedc-1b5e-4803-9617-58d705cda726	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201889 application number: ANDA201889 ndc (product): 70518-4683
Rasagiline	RASAGILINE	NorthStar RxLLC	8bf8e76c-27cb-42a4-aa9c-bdade68c463b	2023-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201889 application number: ANDA201889

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LH8C2JI290	RASAGILINE MESYLATE	161735-79-1	RASAGILINE MESYLATE
003N66TS6T	RASAGILINE	136236-51-6	Rasagiline

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4683-0	70518468300	50 POUCH in 1 BOX (70518-4683-0) / 1 TABLET in 1 POUCH (70518-4683-1)	50 pouch	2026-06-26	No	No	Current