MedPath
FDA Product

metoprolol succinate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

metoprolol succinate

50090-5413

Regulatory Information

50090-5413

ANDA204161

C73584

June 30, 2018

USA

These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS. METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

830016429

Active Ingredients

ACETYLTRIBUTYL CITRATE

Code: 0ZBX0N59RZ

Class Code: IACT

CROSPOVIDONE, UNSPECIFIED

Code: 2S7830E561

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

POLYETHYLENE GLYCOL 6000

Code: 30IQX730WE

Class Code: IACT

POLYETHYLENE GLYCOL 8000

Code: Q662QK8M3B

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

METOPROLOL SUCCINATE

Quantity: 100 mg in 1 1

Code: TH25PD4CCB

Class Code: ACTIR

ETHYLCELLULOSE, UNSPECIFIED

Code: 7Z8S9VYZ4B

Class Code: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

Active Moieties

METOPROLOL

Code: GEB06NHM23

© Copyright 2025. All Rights Reserved by MedPath