Selegiline Hydrochloride

Basic Information

Product Name

FDA Product Code

60505-3438

Regulatory Information

NDC Product Code

60505-3438

Application Number

ANDA074871

Marketing Category

C73584

Effective Date

December 15, 2023

Territorial Authority

USA

FDA Title

Selegiline Hydrochloride Tablets USP 5 mg

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CITRIC ACID MONOHYDRATE

Code: 2968PHW8QP

Class Code: IACT

Selegiline Hydrochloride

Quantity: 5 mg in 1 1

Code: 6W731X367Q

Class Code: ACTIB

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

Selegiline

Code: 2K1V7GP655

Basic Information

Regulatory Information

Company Information

Active Ingredients

MAGNESIUM STEARATE

CITRIC ACID MONOHYDRATE

ANHYDROUS LACTOSE

MICROCRYSTALLINE CELLULOSE

Active Moieties

Selegiline