Metoprolol Tartrate and Hydrochlorothiazide

Basic Information

Product Name

FDA Product Code

62332-117

Regulatory Information

NDC Product Code

62332-117

Application Number

ANDA202870

Marketing Category

C73584

Effective Date

January 5, 2024

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE TABLETS METOPROLOL TARTRATE and HYDROCHLOROTHIAZIDE TABLETS, for oral use Initial U.S. Approval: 1984

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

METOPROLOL TARTRATE

Quantity: 100 mg in 1 1

Code: W5S57Y3A5L

Class Code: ACTIB

HYDROCHLOROTHIAZIDE

Quantity: 50 mg in 1 1

Code: 0J48LPH2TH

Class Code: ACTIB

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

METOPROLOL

Code: GEB06NHM23

HYDROCHLOROTHIAZIDE

Code: 0J48LPH2TH

Basic Information

Regulatory Information

Company Information

Active Ingredients

SODIUM STARCH GLYCOLATE TYPE A POTATO

SILICON DIOXIDE

STARCH, CORN

POVIDONE, UNSPECIFIED

ANHYDROUS LACTOSE

MICROCRYSTALLINE CELLULOSE

MAGNESIUM STEARATE

Active Moieties

METOPROLOL

HYDROCHLOROTHIAZIDE