Selegiline Hydrochloride

Product NDC
60429-176
11-digit product format
604290176
Labeler code
60429
Product ID
60429-176_445cd6b2-2a0f-5f90-e063-6294a90ab877
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selegiline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA074871
Marketing category
ANDA
Marketing start
1997-06-06
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
A074871-001SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074871-001AB

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 UTC2026-02A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-063f01610625f2…
2019-09-15 20:21 UTC2019-09A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074871-001SELEGILINE HYDROCHLORIDE5MGTABLET / ORALABRS1997-06-06cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074871-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074871-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074871-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074871-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074871-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074871-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074871-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074871-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074871-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074871-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074871-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074871-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074871-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074871-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074871-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074871-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074871-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074871-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074871-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074871-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074871-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074871-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074871-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074871-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074871-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074871-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074871-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074871-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074871-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074871-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074871-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074871-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074871-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074871-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074871-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074871-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074871-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074871-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074871-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074871-001AB1cb3db0bc1861…

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
040a97e5-efd1-4a2f-b737-2f13e5366d70Available 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
60429-176-60Selegiline Hydrochloride60 in 1 BOTTLETABLET6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-176-60EA - Each60429-1760fc0585e-95ba-4a29-912e-9a166f3928c312014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SELEGILINE HYDROCHLORIDEACTIVE INGREDIENT6W731X367QSELEGILINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SELEGILINEACTIVE MOIETY2K1V7GP655SELEGILINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSELEGILINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USELEGILINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSELEGILINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SELEGILINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-176SELEGILINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]9Current NDC, Legacy NDC, 1 package rows20241212_040a97e5-efd1-4a2f-b737-2f13e5366d70.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
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEGolden State Medical Supply, Inc.040a97e5-efd1-4a2f-b737-2f13e5366d702025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074871
application number: ANDA074871
ndc (product): 60429-176
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEApotex Corp.2aa9f8ee-6a86-6cf1-bec7-6a1ffa5e1ae22025-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074871
application number: ANDA074871
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEA-S Medication Solutionsf286c854-3b8c-44a8-b3b5-c828dbabb2072023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074871
application number: ANDA074871

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859193selegiline HCl 5 MG Oral TabletPSN040a97e5-efd1-4a2f-b737-2f13e5366d7010
859193selegiline hydrochloride 5 MG Oral TabletSCD040a97e5-efd1-4a2f-b737-2f13e5366d7010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-176-606042901766060 TABLET in 1 BOTTLE (60429-176-60) 60 tablet2013-04-020000-00-00NoNoCurrent