Home NDC 14445-105 Rasagiline Mesylate
Product NDC 14445-105
11-digit product format 144450105
Labeler code 14445
Product ID 14445-105_12d1e116-3a2d-4418-b544-99b18007398b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rasagiline Mesylate
Dosage form TABLET
Route ORAL
Labeler Indoco Remedies Limited
Application ANDA206153
Marketing category ANDA
Marketing start 2015-01-01
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 2020-12-31
Current FDA listing Historical FDA.report record 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.
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 RLD / RS 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.
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.