SELEGILINE HYDROCHLORIDE

Product NDC
67253-700
11-digit product format
672530700
Labeler code
67253
Product ID
67253-700_5a997369-4215-40a1-9570-a3f9494762c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SELEGILINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Par Pharmaceutical
Application
ANDA075352
Marketing category
ANDA
Marketing start
2006-11-04
Marketing end
2020-01-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67253-700DDiscontinued by firm2026-08-03
excluded packagepackage67253-70067253-700-06DDiscontinued by firm2026-08-03

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67253-700-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67253-700-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67253-700-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67253-700-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67253-700-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67253-700-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67253-700-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67253-700-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67253-700-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67253-700-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67253-700-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67253-700-06557ba5c1ecfa…9c80585c8c6e…

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
A075352-001SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075352-001AB

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 UTC2026-02A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORAL1998-11-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORAL1998-11-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORAL1998-11-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORAL1998-11-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-303f01610625f2…
2019-09-15 20:21 UTC2019-09A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075352-001SELEGILINE HYDROCHLORIDE5MGCAPSULE / ORALAB1998-11-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075352-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075352-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075352-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075352-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075352-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075352-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075352-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075352-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075352-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075352-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075352-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075352-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075352-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075352-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075352-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075352-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075352-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075352-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075352-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075352-001AB1782e0a99824c…
2019-12-14 00:12 UTC2019-12A075352-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075352-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075352-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075352-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075352-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075352-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075352-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075352-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075352-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075352-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075352-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075352-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075352-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075352-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075352-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075352-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075352-001AB1a50c72e98297…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67253-700-06EA - Each67253-700307c22f9-c0ba-4f16-a5d2-f5e59438396912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SELEGILINE HYDROCHLORIDEACTIVE INGREDIENT6W731X367QSELEGILINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SELEGILINE HYDROCHLORIDEACTIVE INGREDIENT6W731X367QSELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SELEGILINE HYDROCHLORIDEACTIVE INGREDIENT6W731X367QSELEGILINE HYDROCHLORIDE CAPSULE [DAVA PHARMACEUTICALS, INC.]2
SELEGILINEACTIVE MOIETY2K1V7GP655SELEGILINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
SELEGILINEACTIVE MOIETY2K1V7GP655SELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SELEGILINEACTIVE MOIETY2K1V7GP655SELEGILINE HYDROCHLORIDE CAPSULE [DAVA PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USELEGILINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USELEGILINE HYDROCHLORIDE CAPSULE [DAVA PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSELEGILINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSELEGILINE HYDROCHLORIDE CAPSULE [DAVA PHARMACEUTICALS, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SELEGILINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LSELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LSELEGILINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSELEGILINE HYDROCHLORIDE CAPSULE [DAVA PHARMACEUTICALS, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSELEGILINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SELEGILINE HYDROCHLORIDE CAPSULE [DAVA PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SELEGILINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSELEGILINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSELEGILINE HYDROCHLORIDE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]2

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 HYDROCHLORIDEMarlex Pharmaceuticals, Inc.df88d6bf-0fda-3825-e053-2a95a90a3a752025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075352
application number: ANDA075352
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDEBryant Ranch Prepackb8eb0a00-adc7-4aaf-987c-fa1b207b29962025-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075352
application number: ANDA075352
Selegiline HydrochlorideSELEGILINE HYDROCHLORIDENovitium Pharma LLCe42d99b0-c62e-49d4-b792-1301bb539b922021-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075352
application number: ANDA075352

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859186selegiline HCl 5 MG Oral CapsulePSNdcd786c2-fdf6-46fd-b05f-1618ab6536ab3
859186selegiline hydrochloride 5 MG Oral CapsuleSCDdcd786c2-fdf6-46fd-b05f-1618ab6536ab3