SELEGILINE HYDROCHLORIDE

Product NDC
60505-0055
11-digit product format
605050055
Labeler code
60505
Product ID
60505-0055_2a0cd745-7f62-19e1-d623-fea131789df0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SELEGILINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA075321
Marketing category
ANDA
Marketing start
1997-07-15
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

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
Rxcui859186

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
6780a268-60d0-4c35-b9cf-cd4360ac8329Product name120190702
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
897f5455-61fe-1903-6c67-bd52e2f7ffbeProduct name120140508
98710086-9ad6-ee93-d125-b72fb2fc859aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0055-1SELEGILINE HYDROCHLORIDE60 in 1 BOTTLECAPSULE608
60505-0055-2SELEGILINE HYDROCHLORIDE1000 in 1 BOTTLECAPSULE10008
60505-0055-3SELEGILINE HYDROCHLORIDE500 in 1 BOTTLECAPSULE5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0055-1EA - Each60505-0055a037ebd9-1048-4870-82a9-f32dde5a7d0412012-07-24
60505-0055-2EA - Each60505-0055ab98d637-c295-434b-941d-081a45803cb612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SELEGILINE HYDROCHLORIDEACTIVE INGREDIENT6W731X367QSELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
SELEGILINEACTIVE MOIETY2K1V7GP655SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MSELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XSELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
GELATININACTIVE INGREDIENT2G86QN327LSELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TSELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
SHELLACINACTIVE INGREDIENT46N107B71OSELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
TALCINACTIVE INGREDIENT7SEV7J4R1USELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3
WATERINACTIVE INGREDIENT059QF0KO0RSELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0055SELEGILINE HYDROCHLORIDE CAPSULE [APOTEX CORP.]7Current NDC, Legacy NDC, 3 package rows20241003_1924db3d-6a16-4496-cfd0-6903be146925.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859186selegiline HCl 5 MG Oral CapsulePSN1924db3d-6a16-4496-cfd0-6903be1469258
859186selegiline hydrochloride 5 MG Oral CapsuleSCD1924db3d-6a16-4496-cfd0-6903be1469258

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0055-16050500550160 CAPSULE in 1 BOTTLE (60505-0055-1) 60 capsule1997-07-150000-00-00NoNoCurrent
60505-0055-2605050055021000 CAPSULE in 1 BOTTLE (60505-0055-2) 1000 capsule1997-07-150000-00-00NoNoCurrent
60505-0055-360505005503500 CAPSULE in 1 BOTTLE (60505-0055-3) 500 capsule1997-07-150000-00-00NoNoCurrent