pregabalin 25 mg
1 INDICATIONS AND USAGE 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 4 years of age and older ( 1 ) Fibromyalgia ( 1 ) Neuropathic pain associated with spinal cord injury ( 1 ) 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 4 years of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury Pediatric use information is approved for Pfizer's LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Cipla USA Inc.
CAPSULE WHITE Cipla 25 mg 677
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16 HOW SUPPLIED/STORAGE AND HANDLING 25 mg capsules: white to off white powder filled in size '4' hard gelatin white opaque and white opaque capsule linear printed in black ink with 'Cipla 25 mg' on the cap and '677' on the body; available in: Blister of 10's (NDC 69097-677-19) Carton of 10's x 10's unit-dose capsules (NDC 69097-677-21) Bottle of 30's count with child-resistant cap (NDC 69097-677-02) Bottle of 90's count with child-resistant cap (NDC 69097-677-05) Bottle of 500's count (NDC 69097-677-12) 50 mg capsules: white to off white powder filled in size '3' hard gelatin white opaque and white opaque capsule linear printed in black ink with 'Cipla 50 mg' on the cap and '678' on the body; available in: Blister of 10's (NDC 69097-678-19) Carton of 10's x 10's unit-dose capsules (NDC 69097-678-21) Bottle of 30's count with child-resistant cap (NDC 69097-678-02) Bottle of 90's count with child-resistant cap (NDC 69097-678-05) Bottle of 500's count (NDC 69097-678-12) 75 mg capsules: white to off white powder filled in size '4' hard gelatin orange opaque and white opaque capsule linear printed in black ink with 'Cipla 75 mg' on the cap and '679' on the body; available in: Blister of 10's (NDC 69097-679-19) Carton of 10's x 10's unit-dose capsules (NDC 69097-679-21) Bottle of 30's count with child-resistant cap (NDC 69097-679-02) Bottle of 90's count with child-resistant cap (NDC 69097-679-05) Bottle of 500's count (NDC 69097-679-12) 100 mg capsules: white to off white powder filled in size '3' hard gelatin orange opaque and orange opaque capsule linear printed in black ink with 'Cipla 100 mg' on the cap and '681' on the body; available in: Blister of 10's (NDC 69097-681-19) Carton of 10's x 10's unit-dose capsules (NDC 69097-681-21) Bottle of 30's count with child-resistant cap (NDC 69097-681-02) Bottle of 90's count with child-resistant cap (NDC 69097-681-05) Bottle of 500's count (NDC 69097-681-12) 150 mg capsules: white to off white powder filled in size '2' hard gelatin white opaque and white opaque capsule linear printed in black ink with 'Cipla 150 mg' on the cap and '682' on the body; available in: Blister of 10's (NDC 69097-682-19) Carton of 10's x 10's unit-dose capsules (NDC 69097-682-21) Bottle of 30's count with child-resistant cap (NDC 69097-682-02) Bottle of 90's count with child-resistant cap (NDC 69097-682-05) Bottle of 500's count (NDC 69097-682-12) 200 mg capsules: white to off white powder filled in size '1' hard gelatin light orange opaque and light orange opaque capsule linear printed in black ink with 'Cipla 200 mg' on the cap and '683' on the body; available in: Blister of 10's (NDC 69097-683-19) Carton of 10's x 10's unit-dose capsules (NDC 69097-683-21) Bottle of 30's count with child-resistant cap (NDC 69097-683-02) Bottle of 90's count with child-resistant cap (NDC 69097-683-05) Bottle of 500's count (NDC 69097-683-12) 225 mg capsules: white to off white powder filled in size '1' hard gelatin light orange opaque and white opaque capsule linear printed in black ink with 'Cipla 225 mg' on the cap and '684' on the body; available in: Blister of 10's (NDC 69097-684-19) Carton of 10's x 10's unit-dose capsules (NDC 69097-684-21) Bottle of 30's count with child-resistant cap (NDC 69097-684-02) Bottle of 90's count with child-resistant cap (NDC 69097-684-05) Bottle of 500's count (NDC 69097-684-12) 300 mg capsules: white to off white powder filled in size '0' hard gelatin orange opaque and white opaque capsule linear printed in black ink with 'Cipla 300 mg' on the cap and '685' on the body; available in: Blister of 10's (NDC 69097-685-19) Carton of 10's x 10's unit-dose capsules (NDC 69097-685-21) Bottle of 30's count with child-resistant cap (NDC 69097-685-02) Bottle of 90's count with child-resistant cap (NDC 69097-685-05) Bottle of 500's count (NDC 69097-685-12) Storage and Handling Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).
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