Rasagiline

Product NDC: 84386-170
11-digit product format: 843860170
Labeler code: 84386
Product ID: 84386-170_68cef20f-10c0-475e-af95-b7799355c7e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rasagiline
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA201971
Marketing category: ANDA
Marketing start: 2026-10-20
Substance: RASAGILINE MESYLATE
Active strength: 1 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 45.

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
A201971-001	RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB		2017-05-15
A201971-002	RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB		2017-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201971-001	AB
A201971-002	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 · 90 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
2026-11-14 07:37:17	2026-10	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201971-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2017-05-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201971-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2017-05-15	`5d02ea3f76ae…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A201971-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201971-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201971-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201971-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201971-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201971-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201971-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201971-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201971-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201971-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201971-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201971-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201971-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201971-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201971-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201971-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201971-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201971-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201971-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201971-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201971-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201971-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201971-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201971-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201971-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201971-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201971-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201971-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201971-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201971-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201971-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201971-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201971-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201971-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201971-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201971-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201971-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A201971-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201971-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A201971-002	AB	1	`3bdfa0b2c4d7…`

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	1 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
608328	Internal RxNorm lookup
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
68cef20f-10c0-475e-af95-b7799355c7e9	Available on FDA.report

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
84386-170-30	84386017030	30 TABLET in 1 BOTTLE (84386-170-30)	30 tablet	2026-10-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rasagiline	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2026-10-23	Human Prescription Drug Label	1