Selegiline Hydrochloride

Product NDC
73141-006
11-digit product format
731410006
Labeler code
73141
Product ID
73141-006_339f9a9e-dffc-daac-e063-6294a90ae1fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selegiline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A2A Integrated Pharmaceuticals
Application
ANDA074672
Marketing category
ANDA
Marketing start
2024-03-15
Substance
SELEGILINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074672-001SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074672-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORAL1997-04-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORAL1997-04-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORAL1997-04-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORAL1997-04-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORAL1997-04-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORAL1997-04-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORAL1997-04-013f01610625f2…
2019-09-15 20:21 UTC2019-09A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORAL1997-04-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORAL1997-04-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074672-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALAB1997-04-01cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074672-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074672-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074672-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074672-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074672-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074672-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074672-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074672-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074672-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074672-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074672-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074672-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074672-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074672-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074672-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074672-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074672-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A074672-001AB1bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074672-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074672-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074672-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074672-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074672-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074672-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074672-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074672-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074672-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074672-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074672-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074672-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074672-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074672-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELEGILINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6W731X367QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
859193Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a59ff47b-4379-44f3-9d2c-f8c6121d1881Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6780a268-60d0-4c35-b9cf-cd4360ac8329Product name120190702
897f5455-61fe-1903-6c67-bd52e2f7ffbeProduct name120140508
98710086-9ad6-ee93-d125-b72fb2fc859aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73141-006-02Selegiline Hydrochloride60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73141-006-02EA - Each73141-0069e00c5ed-a4df-4a42-8049-3ddb1d1724e112024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73141-006SELEGILINE HYDROCHLORIDE TABLET [A2A INTEGRATED PHARMACEUTICALS]2Current NDC, 1 package rows20250427_a59ff47b-4379-44f3-9d2c-f8c6121d1881.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEA2A Integrated Pharmaceuticalsa59ff47b-4379-44f3-9d2c-f8c6121d18812025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074672
application number: ANDA074672
ndc (product): 73141-006
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEi3 Pharmaceuticals, LLCc81e983b-455d-2e65-e053-2a95a90a31232024-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074672
application number: ANDA074672

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859193selegiline HCl 5 MG Oral TabletPSNa59ff47b-4379-44f3-9d2c-f8c6121d18812
859193selegiline hydrochloride 5 MG Oral TabletSCDa59ff47b-4379-44f3-9d2c-f8c6121d18812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73141-006-027314100060260 TABLET in 1 BOTTLE (73141-006-02) 60 tablet2024-03-15NoNoCurrent