Drugplain

Bosentan 125 mg/1

Bosentan · TABLET, FILM COATED · Sun Pharmaceutical Industries, Inc.

No Recall History
Plain English

Bosentan is a tablet, film coated containing bosentan at 125 mg/1, taken oral. Manufactured by Sun Pharmaceutical Industries, Inc..

Key Facts

Brand Name
Bosentan
Generic Name
Bosentan
NDC Code (Product)
47335-039
Manufacturer
Sun Pharmaceutical Industries, Inc.
Strength
125 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA209324
Marketing Start
04/26/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea1,003 reports
death714 reports
off label use686 reports
fatigue628 reports
product dose omission issue615 reports
headache530 reports
diarrhoea450 reports
drug ineffective377 reports
malaise373 reports
nausea371 reports

Full Prescribing Information

Full prescribing information not available for this product.

Frequently Asked Questions

What is Bosentan used for?

Bosentan contains Bosentan. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Bosentan a controlled substance?

Bosentan is not classified as a controlled substance by the DEA.

What is the generic name for Bosentan?

The generic name for Bosentan is Bosentan. There are 7 other brand versions of Bosentan.

What is the NDC code for Bosentan 125 mg/1?

The NDC (National Drug Code) for Bosentan 125 mg/1 is 47335-039, listed by Sun Pharmaceutical Industries, Inc..

Product NDC

47335-039

Package NDC

47335-039-64

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)