Rasagiline

Product NDC
67877-259
11-digit product format
678770259
Labeler code
67877
Product ID
67877-259_f8b285b7-ed55-4260-bbc7-ebfdff15f6c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rasagiline
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA201889
Marketing category
ANDA
Marketing start
2017-10-30
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
A201889-001RASAGILINE MESYLATERASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-30
A201889-002RASAGILINE MESYLATERASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201889-001AB
A201889-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201889-001RASAGILINE MESYLATEEQ 0.5MG BASETABLET / ORALAB2017-10-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A201889-002RASAGILINE MESYLATEEQ 1MG BASETABLET / ORALAB2017-10-30782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201889-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201889-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201889-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201889-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201889-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201889-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201889-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201889-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201889-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201889-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201889-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201889-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201889-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201889-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201889-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201889-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201889-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201889-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201889-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201889-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201889-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201889-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201889-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201889-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201889-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201889-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201889-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201889-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201889-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201889-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201889-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201889-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201889-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201889-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201889-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201889-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201889-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201889-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201889-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A201889-002AB1782e0a99824c…

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
5dfeec8f-f4f3-4e06-915e-3244467516a6Available 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
67877-259-30Rasagiline30 in 1 BOTTLETABLET3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-259-30EA - Each67877-259302a526d-67b4-4b6f-a695-baeb7d165bf512017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-259RASAGILINE TABLET [ASCEND LABORATORIES, LLC]14Current NDC, Legacy NDC, 1 package rows20221001_5dfeec8f-f4f3-4e06-915e-3244467516a6.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RasagilineRASAGILINEREMEDYREPACK INC.fdebcedc-1b5e-4803-9617-58d705cda7262026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201889
application number: ANDA201889
RasagilineRASAGILINENorthStar RxLLC8bf8e76c-27cb-42a4-aa9c-bdade68c463b2023-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201889
application number: ANDA201889
RasagilineRASAGILINEAscend Laboratories, LLC5dfeec8f-f4f3-4e06-915e-3244467516a62022-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201889
application number: ANDA201889
ndc (product): 67877-259

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636664rasagiline 0.5 MG Oral TabletPSN5dfeec8f-f4f3-4e06-915e-3244467516a614
608328rasagiline 1 MG Oral TabletPSN5dfeec8f-f4f3-4e06-915e-3244467516a614
636664rasagiline 0.5 MG Oral TabletSCD5dfeec8f-f4f3-4e06-915e-3244467516a614
608328rasagiline 1 MG Oral TabletSCD5dfeec8f-f4f3-4e06-915e-3244467516a614
636664rasagiline (as rasagiline mesylate) 0.5 MG Oral TabletSY5dfeec8f-f4f3-4e06-915e-3244467516a614
608328rasagiline (as rasagiline mesylate) 1 MG Oral TabletSY5dfeec8f-f4f3-4e06-915e-3244467516a614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-259-306787702593030 TABLET in 1 BOTTLE (67877-259-30) 30 tablet2017-10-300000-00-00NoNoCurrent