Drugplain

Gablofen 500 ug/mL

Baclofen Injection · INJECTION, SOLUTION · Piramal Critical Care Inc

No Recall History
Plain English

Gablofen is a injection, solution containing baclofen injection at 500 ug/mL, taken intrathecal. Manufactured by Piramal Critical Care Inc.

Key Facts

Brand Name
Gablofen
Generic Name
Baclofen Injection
NDC Code (Product)
66794-155
Manufacturer
Piramal Critical Care Inc
Strength
500 ug/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRATHECAL
Marketing Status
Application #
NDA022462
Drug Class
gamma-Aminobutyric Acid-ergic Agonist [EPC]
Marketing Start
04/01/2017

Recall History

No Recall History

Side Effects Reported to FDA

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

muscle spasticity760 reports
withdrawal syndrome402 reports
device issue376 reports
drug ineffective292 reports
drug withdrawal syndrome272 reports
overdose170 reports
implant site infection161 reports
infection161 reports
hypertonia156 reports
device failure154 reports

Frequently Asked Questions

What is Gablofen used for?

Gablofen contains Baclofen Injection. It is a injection, solution taken intrathecal. Consult your doctor for specific uses.

Is Gablofen a controlled substance?

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

What is the generic name for Gablofen?

The generic name for Gablofen is Baclofen Injection. There are no other listed brand versions of Baclofen Injection.

What is the NDC code for Gablofen 500 ug/mL?

The NDC (National Drug Code) for Gablofen 500 ug/mL is 66794-155, listed by Piramal Critical Care Inc.

Product NDC

66794-155

Package NDC

66794-155-01

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

Data from openFDA · Public domain (CC0 1.0)