Home NDC 72162-2383 RASAGILINE
Product NDC 72162-2383
11-digit product format 721622383
Labeler code 72162
Product ID 72162-2383_5bf23576-46d9-4649-9a7a-38ae33e0bde1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rasagiline
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA207004
Marketing category ANDA
Marketing start 2019-04-03
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 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 A207004-001 RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 A207004-002 RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29
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 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 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207004-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2019-03-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207004-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2019-03-29 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base RASAGILINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RASAGILINE MESYLATE 1 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 608328 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72162-2383-3 RASAGILINE 30 in 1 BOTTLE TABLET 30 100
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-2383 RASAGILINE (RASAGILINE) TABLET [BRYANT RANCH PREPACK] 100 Current NDC, 1 package rows 20240816_4c4f5042-0e21-40a0-8352-bb28bb752bfa.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72162-2383-3 72162238303 30 TABLET in 1 BOTTLE (72162-2383-3) 30 tablet 2024-08-15 No No Current