FDA.reportPublic FDA data

Selegiline Hydrochloride

Product NDC
60505-3438
11-digit product format
605053438
Labeler code
60505
Product ID
60505-3438_1f213cd2-ca80-aa07-6f27-a5093d23da13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selegiline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA074871
Marketing category
ANDA
Marketing start
1997-07-06
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

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 Identifiers#

Field, Values table
FieldValues
Unii6W731X367Q
Rxcui859193

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
60505-3438-3Selegiline Hydrochloride60 in 1 BOTTLETABLET607
60505-3438-8Selegiline Hydrochloride500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3438-3EA - Each60505-3438d6160ce2-69ce-4c73-851e-0dd4adda78b512013-02-13
60505-3438-8EA - Each60505-3438501d9e74-a6ce-44e0-8290-4c49e8b5004712013-02-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3438SELEGILINE HYDROCHLORIDE TABLET [APOTEX CORP.]6Current NDC, Legacy NDC, 2 package rows20241003_2aa9f8ee-6a86-6cf1-bec7-6a1ffa5e1ae2.zip

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
859193selegiline HCl 5 MG Oral TabletPSNf286c854-3b8c-44a8-b3b5-c828dbabb2079
859193selegiline hydrochloride 5 MG Oral TabletSCDf286c854-3b8c-44a8-b3b5-c828dbabb2079
859193selegiline HCl 5 MG Oral TabletPSN2aa9f8ee-6a86-6cf1-bec7-6a1ffa5e1ae27
859193selegiline hydrochloride 5 MG Oral TabletSCD2aa9f8ee-6a86-6cf1-bec7-6a1ffa5e1ae27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-3438-36050534380360 TABLET in 1 BOTTLE (60505-3438-3) 60 tablet1997-07-060000-00-00NoNoCurrent
60505-3438-860505343808500 TABLET in 1 BOTTLE (60505-3438-8) 500 tablet1997-07-060000-00-00NoNoCurrent