Rasagiline

Product NDC
80005-141
11-digit product format
800050141
Labeler code
80005
Product ID
80005-141_0be04379-452a-455f-8df6-bd319391580a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rasagiline mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Carnegie Pharmaceuticals LLC
Application
ANDA201942
Marketing category
ANDA
Marketing start
2026-01-15
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201942-001RASAGILINE MESYLATERASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2021-11-18
A201942-002RASAGILINE MESYLATERASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2021-11-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A201942-001AB
A201942-002AB

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 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2021-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2021-11-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-184b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2021-11-18782e0a99824c…
2021-12-28 21:50 UTC2021-12A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2021-11-18782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201942-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORAL2021-11-186a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201942-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORAL2021-11-186a51e52b5d6a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201942-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201942-002AB1011fe1cb6892…
2021-12-28 21:50 UTC2021-12A201942-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A201942-002AB1782e0a99824c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A201942-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A201942-002AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Rasagiline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RASAGILINE MESYLATE.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LH8C2JI290Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
608328Internal RxNorm lookup
636664Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e84da5ee-f93a-4e0e-9120-7dfcb9d18430Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e9145103-bd6e-1983-a11c-ef9ba78a1125Product name920250303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80005-141-08Rasagiline30 in 1 BOTTLETABLET301
80005-141-10Rasagiline90 in 1 BOTTLETABLET901
80005-141-14Rasagiline500 in 1 BOTTLETABLET5001

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RasagilineRASAGILINE MESYLATEGolden State Medical Supply, Inc.4ee5cc48-7e1e-b268-e063-6394a90a56292026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201942
application number: ANDA201942
RasagilineRASAGILINE MESYLATECarnegie Pharmaceuticals LLCe84da5ee-f93a-4e0e-9120-7dfcb9d184302025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201942
application number: ANDA201942
ndc (product): 80005-141

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636664rasagiline 0.5 MG Oral TabletPSN4ee5cc48-7e1e-b268-e063-6394a90a56292
608328rasagiline 1 MG Oral TabletPSN4ee5cc48-7e1e-b268-e063-6394a90a56292
636664rasagiline 0.5 MG Oral TabletSCD4ee5cc48-7e1e-b268-e063-6394a90a56292
608328rasagiline 1 MG Oral TabletSCD4ee5cc48-7e1e-b268-e063-6394a90a56292
636664rasagiline (as rasagiline mesylate) 0.5 MG Oral TabletSY4ee5cc48-7e1e-b268-e063-6394a90a56292
608328rasagiline (as rasagiline mesylate) 1 MG Oral TabletSY4ee5cc48-7e1e-b268-e063-6394a90a56292
636664rasagiline 0.5 MG Oral TabletPSNe84da5ee-f93a-4e0e-9120-7dfcb9d184301
608328rasagiline 1 MG Oral TabletPSNe84da5ee-f93a-4e0e-9120-7dfcb9d184301
636664rasagiline 0.5 MG Oral TabletSCDe84da5ee-f93a-4e0e-9120-7dfcb9d184301
608328rasagiline 1 MG Oral TabletSCDe84da5ee-f93a-4e0e-9120-7dfcb9d184301
636664rasagiline (as rasagiline mesylate) 0.5 MG Oral TabletSYe84da5ee-f93a-4e0e-9120-7dfcb9d184301
608328rasagiline (as rasagiline mesylate) 1 MG Oral TabletSYe84da5ee-f93a-4e0e-9120-7dfcb9d184301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80005-141-088000501410830 TABLET in 1 BOTTLE (80005-141-08) 30 tablet2026-01-15NoNoCurrent
80005-141-108000501411090 TABLET in 1 BOTTLE (80005-141-10) 90 tablet2026-01-15NoNoCurrent
80005-141-1480005014114500 TABLET in 1 BOTTLE (80005-141-14) 500 tablet2026-01-15NoNoCurrent