Home NDC 16714-770-01 Rasagiline
Product NDC 16714-770
Requested package NDC 16714-770-01
11-digit product format 167140770
Labeler code 16714
Product ID 16714-770_dfffedf4-c1f0-4bbd-9978-80dcec656d72
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rasagiline
Dosage form TABLET
Route ORAL
Labeler NorthStar RxLLC
Application ANDA201889
Marketing category ANDA
Marketing start 2018-04-17
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 A201889-001 RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 A201889-002 RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30
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 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201889-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2017-10-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A201889-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2017-10-30 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 .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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16714-770-01 Rasagiline 30 in 1 BOTTLE TABLET 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-770 RASAGILINE TABLET [NORTHSTAR RXLLC] 4 Current NDC, Legacy NDC, 1 package rows 20231227_8bf8e76c-27cb-42a4-aa9c-bdade68c463b.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16714-770-01 16714077001 30 TABLET in 1 BOTTLE (16714-770-01) 30 tablet 2018-04-17 0000-00-00 No No Current