Rasagiline

Product NDC: 33342-308
11-digit product format: 333420308
Labeler code: 33342
Product ID: 33342-308_1650fc1f-ed87-411c-af06-97b9ff242da7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rasagiline
Dosage form: TABLET
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA208866
Marketing category: ANDA
Marketing start: 2024-06-29
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: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208866-001	RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB		2024-06-28
A208866-002	RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB		2024-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208866-001	AB
A208866-002	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.

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	A208866-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208866-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208866-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208866-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208866-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208866-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208866-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208866-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208866-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208866-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208866-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208866-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208866-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208866-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208866-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208866-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208866-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208866-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208866-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208866-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208866-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208866-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208866-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208866-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-06-28	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208866-001	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	2024-06-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208866-002	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-06-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208866-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208866-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208866-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208866-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208866-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208866-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208866-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208866-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208866-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208866-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208866-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208866-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208866-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208866-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208866-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208866-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208866-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208866-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208866-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208866-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208866-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208866-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208866-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208866-002	AB	1	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208866-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208866-002	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Rasagiline
Listing expiration: 2026-12-31

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 · 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
e8771c7e-5ecf-47dc-a0fd-4d12e85631a6	Available on FDA.report

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
33342-308-07	Rasagiline	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33342-308-07	EA - Each	33342-308	1b417084-7216-42bc-9a72-a2e4f1a7f9e4	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33342-308	RASAGILINE TABLET [MACLEODS PHARMACEUTICALS LIMITED]	1	Current NDC, 1 package rows	20240719_e8771c7e-5ecf-47dc-a0fd-4d12e85631a6.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	RASAGILINE	Macleods Pharmaceuticals Limited	e8771c7e-5ecf-47dc-a0fd-4d12e85631a6	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208866 application number: ANDA208866 ndc (product): 33342-308

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
636664	rasagiline 0.5 MG Oral Tablet	PSN	e8771c7e-5ecf-47dc-a0fd-4d12e85631a6	2
608328	rasagiline 1 MG Oral Tablet	PSN	e8771c7e-5ecf-47dc-a0fd-4d12e85631a6	2
636664	rasagiline 0.5 MG Oral Tablet	SCD	e8771c7e-5ecf-47dc-a0fd-4d12e85631a6	2
608328	rasagiline 1 MG Oral Tablet	SCD	e8771c7e-5ecf-47dc-a0fd-4d12e85631a6	2
636664	rasagiline (as rasagiline mesylate) 0.5 MG Oral Tablet	SY	e8771c7e-5ecf-47dc-a0fd-4d12e85631a6	2
608328	rasagiline (as rasagiline mesylate) 1 MG Oral Tablet	SY	e8771c7e-5ecf-47dc-a0fd-4d12e85631a6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
33342-308-07	33342030807	30 TABLET in 1 BOTTLE (33342-308-07)	30 tablet	2024-06-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rasagiline	Macleods Pharmaceuticals Limited \| OXALIS LABS	2025-08-25	Human Prescription Drug Label	2