Rasagiline mesylate

Product NDC: 23155-747
11-digit product format: 231550747
Labeler code: 23155
Product ID: 23155-747_bec7650d-c8a3-4841-8d06-5f2779961fb6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rasagiline mesylate
Dosage form: TABLET
Route: ORAL
Labeler: Avet Pharmaceuticals Inc.
Application: ANDA206153
Marketing category: ANDA
Marketing start: 2023-05-31
Marketing end: 2026-07-31
Substance: RASAGILINE MESYLATE
Active strength: 1 mg/1
Pharmacologic classes: Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Current FDA listing: Yes

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	23155-747		D	Discontinued by firm		2026-08-11
excluded package	package	23155-747	23155-747-03	D	Discontinued by firm		2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A206153-001	RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB		2019-10-04
A206153-002	RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB		2019-10-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206153-001	AB
A206153-002	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 2 · 78 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
2026-02-19 14:30 UTC	2026-02	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206153-001	RASAGILINE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206153-002	RASAGILINE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206153-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2019-10-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206153-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2019-10-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A206153-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206153-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206153-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206153-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206153-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206153-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206153-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206153-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206153-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206153-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206153-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206153-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206153-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206153-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206153-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206153-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206153-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206153-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206153-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206153-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206153-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206153-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206153-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206153-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206153-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206153-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206153-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206153-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206153-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206153-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206153-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206153-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206153-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206153-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206153-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206153-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206153-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206153-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206153-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206153-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e9145103-bd6e-1983-a11c-ef9ba78a1125	Product name	9	20250303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
23155-747-03	Rasagiline mesylate	30 in 1 BOTTLE	TABLET	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
23155-747-03	EA - Each	23155-747	8e2ef9b0-d8aa-4e35-9077-753f5b27e3b8	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
23155-747	RASAGILINE MESYLATE TABLET [AVET PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 1 package rows	20231030_7d070521-ea04-4483-bdb9-54a8859700df.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rasagiline mesylate	RASAGILINE MESYLATE	Florida Pharmaceutical Products, LLC	3b57a1c9-0ad9-40cf-a972-29851a658489	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206153 application number: ANDA206153

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LH8C2JI290	RASAGILINE MESYLATE	161735-79-1	RASAGILINE MESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
636664	rasagiline 0.5 MG Oral Tablet	PSN	7d070521-ea04-4483-bdb9-54a8859700df	4
608328	rasagiline 1 MG Oral Tablet	PSN	7d070521-ea04-4483-bdb9-54a8859700df	4
636664	rasagiline 0.5 MG Oral Tablet	SCD	7d070521-ea04-4483-bdb9-54a8859700df	4
608328	rasagiline 1 MG Oral Tablet	SCD	7d070521-ea04-4483-bdb9-54a8859700df	4
636664	rasagiline (as rasagiline mesylate) 0.5 MG Oral Tablet	SY	7d070521-ea04-4483-bdb9-54a8859700df	4
608328	rasagiline (as rasagiline mesylate) 1 MG Oral Tablet	SY	7d070521-ea04-4483-bdb9-54a8859700df	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
23155-747-03	23155074703	30 TABLET in 1 BOTTLE (23155-747-03)	30 tablet	2023-10-23	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rasagiline mesylate	Avet Pharmaceuticals Inc. \| INDOCO REMEDIES LIMITED	2025-12-30	Human Prescription Drug Label	4