Home NDC 42291-779-30 Rasagiline
Product NDC 42291-779
Requested package NDC 42291-779-30
11-digit product format 422910779
Labeler code 42291
Product ID 42291-779_ec19a5c9-a071-4082-e053-2995a90aba71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rasagiline
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application NDA021641
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2021-05-20
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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
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.
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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-779 RASAGILINE TABLET [AVKARE] 3 Legacy NDC 20231108_c2c8a281-065a-faf5-e053-2995a90aa13f.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-779-30 42291077930 30 TABLET in 1 BOTTLE (42291-779-30) 30 tablet 2021-05-20 0000-00-00 No No Current