Anastrozole

Basic Information

Product Name

Anastrozole

FDA Product Code

68382-209

Regulatory Information

NDC Product Code

68382-209

Application Number

ANDA078921

Marketing Category

C73584

Effective Date

August 21, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use anastrozole tablets safely and effectively. See full prescribing information for anastrozole tablets. ANASTROZOLE tablet for oral use Initial U.S. Approval: 1995

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ANASTROZOLE

Quantity: 1 mg in 1 1

Code: 2Z07MYW1AZ

Class Code: ACTIB

LACTOSE, UNSPECIFIED FORM

Code: J2B2A4N98G

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

Active Moieties

Code: 2Z07MYW1AZ

Anastrozole

Basic Information

Regulatory Information

Company Information

Active Ingredients

LACTOSE, UNSPECIFIED FORM

MAGNESIUM STEARATE

HYPROMELLOSES

POLYETHYLENE GLYCOL, UNSPECIFIED

SODIUM STARCH GLYCOLATE TYPE A POTATO

TITANIUM DIOXIDE

POVIDONE

Active Moieties

ANASTROZOLE