Selegiline Hydrochloride

Product NDC
10135-737
11-digit product format
101350737
Labeler code
10135
Product ID
10135-737_441eef3c-3c0d-08b3-e063-6394a90afef9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Selegiline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA075352
Marketing category
ANDA
Marketing start
2021-05-01
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
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
10135-737-60Selegiline Hydrochloride60 in 1 BOTTLECAPSULE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-737-60EA - Each10135-737d96fe99d-4cd8-4f18-985a-9924bd5a95a012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-737SELEGILINE HYDROCHLORIDE CAPSULE [MARLEX PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20241019_df88d6bf-0fda-3825-e053-2a95a90a3a75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859186selegiline HCl 5 MG Oral CapsulePSNdf88d6bf-0fda-3825-e053-2a95a90a3a754
859186selegiline hydrochloride 5 MG Oral CapsuleSCDdf88d6bf-0fda-3825-e053-2a95a90a3a754

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-737-601013507376060 CAPSULE in 1 BOTTLE (10135-737-60) 60 capsule2021-05-010000-00-00NoNoCurrent