This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
FDA Drug information

PROPRANOLOL HYDROCHLORIDE

Read time: 1 mins
Marketing start date: 06 Oct 2024

Summary of product characteristics


Effective Time

20221014

Version

4

Spl Product Data Elements

PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE PROPRANOLOL D&C RED NO. 28 ETHYLCELLULOSES FD&C BLUE NO. 1 FERROSOFERRIC OXIDE GELATIN HYPROMELLOSES TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE WHITE LIGHT BLUE CAPSULE ZA;57;60;mg PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE PROPRANOLOL D&C RED NO. 28 ETHYLCELLULOSES FD&C BLUE NO. 1 FERROSOFERRIC OXIDE GELATIN HYPROMELLOSES TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE LIGHT BLUE LIGHT BLUE CAPSULE ZA;58;80;mg PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE PROPRANOLOL D&C RED NO. 28 ETHYLCELLULOSES FD&C BLUE NO. 1 FERROSOFERRIC OXIDE GELATIN HYPROMELLOSES TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE DARK BLUE LIGHT BLUE CAPSULE ZA;59;120;mg PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE PROPRANOLOL ETHYLCELLULOSES FD&C BLUE NO. 1 FERROSOFERRIC OXIDE GELATIN HYPROMELLOSES TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE DARK BLUE DARK BLUE CAPSULE ZA;60;160;mg

Application Number

ANDA090321

Brand Name

PROPRANOLOL HYDROCHLORIDE

Generic Name

PROPRANOLOL HYDROCHLORIDE

Product Ndc

65841-748

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-745-01 in bottle of 100 Capsules Propranolol Hydrochloride Extended-release Capsules USP, 60 mg Rx only 100 CAPSULES NDC 65841-746-01 in bottle of 100 Capsules Propranolol Hydrochloride Extended-release Capsules USP, 80 mg Rx only 100 CAPSULES NDC 65841-747-01 in bottle of 100 Capsules Propranolol Hydrochloride Extended-release Capsules USP, 120 mg Rx only 100 CAPSULES NDC 65841-748-01 in bottle of 100 Capsules Propranolol Hydrochloride Extended-release Capsules USP, 160 mg Rx only 100 CAPSULES Structured formula for propranolol Structured formula for propranolol Structured formula for propranolol Structural formula for propranolol

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.