pregabalin

FDA Drug Profile — pregabalin, PREGABALIN

pregabalin is listed in the FDA National Drug Code directory with 27 NDC codes, marketed under brand names including pregabalin, PREGABALIN. Available dosage forms: capsule, powder.

Drug Details

Generic Name
pregabalin
Brand Names
pregabalin, PREGABALIN
Application Number
ANDA208113
Sponsor
Indoco Remedies Limited
NDC Codes
27
Dosage Forms
CAPSULE, POWDER
Routes
ORAL
Active Ingredients
PREGABALIN

Indications and Usage

1 INDICATIONS AND USAGE Pregabalin capsules are indicated for: • Management of neuropathic pain associated with diabetic peripheral neuropathy • Management of postherpetic neuralgia • Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pregabalin capsules are indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) Postherpetic neuralgia (PHN) ( 1 ) Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older ( 1 ) Fibromyalgia ( 1 ) Neuropathic pain associated with spinal cord injury ( 1 )