Home NDC 83085-007-30 Rasagiline
Product NDC 83085-007
Requested package NDC 83085-007-30
11-digit product format 830850007
Labeler code 83085
Product ID 83085-007_9ce75c86-75fb-4e5d-a5a6-25696c5593f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rasagiline mesylate
Dosage form TABLET
Route ORAL
Labeler SKG Pharma Inc.
Application ANDA218163
Marketing category ANDA
Marketing start 2025-04-04
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 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 83085-007 83085-007-30 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…
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 A218163-001 RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 A218163-002 RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09
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 A218163-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218163-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218163-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218163-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218163-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218163-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218163-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218163-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218163-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218163-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218163-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218163-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218163-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218163-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218163-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218163-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218163-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218163-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218163-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218163-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218163-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218163-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218163-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218163-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218163-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218163-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218163-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A218163-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218163-001 RASAGILINE MESYLATE EQ 0.5MG BASE TABLET / ORAL AB 2024-04-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218163-002 RASAGILINE MESYLATE EQ 1MG BASE TABLET / ORAL AB 2024-04-09 a50c72e98297…
Observed Orange Book normalized TE history# 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 83085-007-10 Rasagiline 1000 in 1 BOTTLE TABLET 1000 3 83085-007-30 Rasagiline 30 in 1 BOTTLE TABLET 30 3 83085-007-50 Rasagiline 500 in 1 BOTTLE TABLET 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83085-007 RASAGILINE (RASAGILINE MESYLATE) TABLET [SKG PHARMA INC.] 3 Current NDC, 3 package rows 20250406_5c234b28-29e7-4149-9505-e2818a692bca.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 83085-007-30 83085000730 30 TABLET in 1 BOTTLE (83085-007-30) 30 tablet 2025-04-04 No No Current