MedPath
FDA Product

Propranolol Hydrochloride

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

Basic Information

Propranolol Hydrochloride

60687-215

Regulatory Information

60687-215

ANDA078703

C73584

November 6, 2023

USA

Propranolol Hydrochloride Extended-Release Capsules, USP 8421501/0623F Rx Only

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

929561009

Active Ingredients

SUCROSE

Code: C151H8M554

Class Code: IACT

ETHYLCELLULOSE (10 MPA.S)

Code: 3DYK7UYZ62

Class Code: IACT

HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)

Code: 87Y6436BKR

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

DIETHYL PHTHALATE

Code: UF064M00AF

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

PROPRANOLOL HYDROCHLORIDE

Quantity: 60 mg in 1 1

Code: F8A3652H1V

Class Code: ACTIB

Active Moieties

PROPRANOLOL

Code: 9Y8NXQ24VQ

© Copyright 2025. All Rights Reserved by MedPath