Selegiline Hydrochloride

Basic Information

Product Name

FDA Product Code

72319-006

Regulatory Information

NDC Product Code

72319-006

Application Number

ANDA074672

Marketing Category

C73584

Effective Date

December 15, 2021

Territorial Authority

USA

FDA Title

Selegiline Hydrochloride Tablets, USP 5 mg

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

MICROCRYSTALLINE CELLULOSE 102

Code: PNR0YF693Y

Class Code: IACT

POVIDONE K25

Code: K0KQV10C35

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

MICROCRYSTALLINE CELLULOSE 101

Code: 7T9FYH5QMK

Class Code: IACT

SELEGILINE HYDROCHLORIDE

Quantity: 5 mg in 1 1

Code: 6W731X367Q

Class Code: ACTIB

Active Moieties

SELEGILINE

Code: 2K1V7GP655

Basic Information

Regulatory Information

Company Information

Active Ingredients

STARCH, CORN

MICROCRYSTALLINE CELLULOSE 102

POVIDONE K25

LACTOSE MONOHYDRATE

STEARIC ACID

MICROCRYSTALLINE CELLULOSE 101

Active Moieties

SELEGILINE