Home NDC 13668-446 RASAGILINE
Product NDC 13668-446
11-digit product format 136680446
Labeler code 13668
Product ID 13668-446_fa1b2a7e-f459-4432-97f2-23d2c07c2dac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RASAGILINE
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA210150
Marketing category ANDA
Marketing start 2025-11-15
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 2027-12-31
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 A210150-001 RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2025-05-05 A210150-002 RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2025-05-05
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.
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 A210150-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2025-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210150-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2025-05-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210150-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2025-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210150-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2025-05-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210150-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2025-05-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210150-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2025-05-05 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210150-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2025-05-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210150-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2025-05-05 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base RASAGILINE
Listing expiration 2027-12-31 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 · 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 13668-446-05 RASAGILINE 500 in 1 CONTAINER TABLET 500 6 13668-446-30 RASAGILINE 30 in 1 CONTAINER TABLET 30 6 13668-446-90 RASAGILINE 90 in 1 CONTAINER TABLET 90 6
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 13668-446-05 13668044605 500 TABLET in 1 CONTAINER (13668-446-05) 500 tablet 2025-11-15 No No Current 13668-446-30 13668044630 30 TABLET in 1 CONTAINER (13668-446-30) 30 tablet 2025-11-15 No No Current 13668-446-90 13668044690 90 TABLET in 1 CONTAINER (13668-446-90) 90 tablet 2025-11-15 No No Current