Azilect

Product NDC: 43353-015
11-digit product format: 433530015
Labeler code: 43353
Product ID: 43353-015_7a05b579-97d9-4b52-8998-b95a634e674e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rasagiline Mesylate
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA021641
Marketing category: NDA
Marketing start: 2006-07-10
Marketing end: 0000-00-00
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: 2019-12-31
Current FDA listing: Historical FDA.report record

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	43353-015		D	Discontinued by firm		2026-08-11
excluded package	package	43353-015	43353-015-18	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-015-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-015-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-015-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-015-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-015-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-015-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-015-18	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-015-18	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-015-18	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-015-18	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-015-18	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-015-18	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-015-18	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-015-18	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-015-18	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43353-015-18	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43353-015-18	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43353-015-18	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	43353-015-18	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	43353-015-18	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	43353-015-18	`9bebd1f3094a…`	`5416666fcb17…`

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
N021641-001	AZILECT	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16
N021641-002	AZILECT	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021641-001	AB
N021641-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021641-001	7572834	2026-12-05		Drug product
N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08
N021641-002	7572834	2026-12-05		Drug product
N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021641-001	AZILECT	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2006-05-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021641-002	AZILECT	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2006-05-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N021641-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021641-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021641-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021641-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021641-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021641-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021641-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021641-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021641-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021641-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021641-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021641-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021641-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021641-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021641-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021641-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021641-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021641-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021641-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021641-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021641-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021641-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021641-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021641-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021641-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021641-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021641-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021641-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021641-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021641-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021641-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021641-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021641-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021641-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021641-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021641-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021641-001	7572834	2026-12-05		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021641-002	7572834	2026-12-05		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021641-001	7572834	2026-12-05		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021641-002	7572834	2026-12-05		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021641-001	7572834	2026-12-05		Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021641-002	7572834	2026-12-05		Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021641-001	7572834	2026-12-05		Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021641-002	7572834	2026-12-05		Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021641-001	7572834	2026-12-05		Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021641-002	7572834	2026-12-05		Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021641-001	7572834	2026-12-05		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021641-002	7572834	2026-12-05		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021641-001	7572834	2026-12-05		Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021641-002	7572834	2026-12-05		Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-001	7572834	2026-12-05		Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-002	7572834	2026-12-05		Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-001	7572834	2026-12-05		Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-002	7572834	2026-12-05		Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021641-001	7572834	2026-12-05		Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021641-001	7815942	2027-08-27	U-219	Drug substance, Drug product	2010-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021641-002	7572834	2026-12-05		Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021641-002	7815942	2027-08-27	U-219	Drug substance, Drug product		`d06236e962d9…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43353-015-18	2020-01-31	C162847	48780-1	9d75b9d0-8c2f-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use AZILECT ® safely and effectively. See full prescribing information for AZILECT . AZILECT (rasagiline mesylate) Tablets for Oral Use Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-015-18	Azilect	3000 in 1 BOTTLE	TABLET	3000		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-015-18	EA - Each	43353-015	2451b029-d0d5-4dba-add4-bfca7cb79a15	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-015	AZILECT (RASAGILINE MESYLATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 1 package rows	20170629_73efe275-acea-49c0-aa76-fdc4249c424e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rasagiline	RASAGILINE	Teva Pharmaceuticals USA, Inc.	e802c83c-e581-4a11-b83d-1df47120078d	2020-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021641 application number: NDA021641
Azilect	RASAGILINE MESYLATE	Teva Neuroscience, Inc.	a40d0e73-3f9f-4b01-979d-402c9cdaeb60	2020-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021641 application number: NDA021641

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
637185	Azilect 1 MG Oral Tablet	PSN	73efe275-acea-49c0-aa76-fdc4249c424e	2
608328	rasagiline 1 MG Oral Tablet	PSN	73efe275-acea-49c0-aa76-fdc4249c424e	2
637185	rasagiline 1 MG Oral Tablet [Azilect]	SBD	73efe275-acea-49c0-aa76-fdc4249c424e	2
608328	rasagiline 1 MG Oral Tablet	SCD	73efe275-acea-49c0-aa76-fdc4249c424e	2
637185	Azilect 1 MG (as rasagiline mesylate) Oral Tablet	SY	73efe275-acea-49c0-aa76-fdc4249c424e	2
637185	Azilect 1 MG Oral Tablet	SY	73efe275-acea-49c0-aa76-fdc4249c424e	2
608328	rasagiline (as rasagiline mesylate) 1 MG Oral Tablet	SY	73efe275-acea-49c0-aa76-fdc4249c424e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-015-18	43353001518	3000 in 1 BOTTLE	Historical