pregabalin 75 mg
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 17 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. 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 17 years of age and older ( 1 ) fibromyalgia ( 1 ) neuropathic pain associated with spinal cord injury ( 1 )
Cipla USA, Inc.
CAPSULE ORANGE 75 mg IG570
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Cipla USA, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
PREGABALIN capsules are supplied as follows: 25 mg capsules: Hard Gelatin capsules Size "4" with white Opaque cap and white Opaque body imprinted with 25 mg on cap and IG568 on body with black ink and filled with white to off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 69097-954-05) and 500’s count (NDC 69097-954-12). 50 mg capsules: Hard Gelatin capsules Size "3" with white Opaque cap and white Opaque body imprinted with 50 mg on cap and IG569 on body with black ink and filled with white to off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 69097-955-05) and 500’s count (NDC 69097-955-12). 75 mg capsules: Hard Gelatin capsules Size "4" with orange Opaque cap and white Opaque body imprinted with 75 mg on cap and IG570 on body with black ink and filled with white to off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 69097-956-05) and 500’s count (NDC 69097-956-12). 100 mg capsules: Hard Gelatin capsules Size "3" with orange Opaque cap and orange Opaque body imprinted with 100 mg on cap and IG571 on body with black ink and filled with white to off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 69097-957-05) and 500’s count (NDC 69097-957-12). 150 mg capsules: Hard Gelatin capsules Size "2" with white Opaque cap and white Opaque body imprinted with 150 mg on cap and IG572 on body with black ink and filled with white to off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 69097-958-05) and 500’s count (NDC 69097-958-12). 200 mg capsules: Hard Gelatin capsules Size "1" with Light orange Opaque cap and Light orange Opaque body imprinted with 200 mg on cap and IG573 on body with black ink and filled with white to off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 69097-959-05) 225 mg capsules: Hard Gelatin capsules Size "1" with Light orange Opaque cap and white Opaque body imprinted with 225 mg on cap and IG574 on body with black ink and filled with white to off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 69097-961-05) 300 mg capsules: Hard Gelatin capsules Size "0" with orange Opaque cap and white Opaque body imprinted with 300 mg on cap and IG575 on body with black ink and filled with white to off-white powder; supplied in bottle of 90’s count with child-resistant cap (NDC 69097-962-05) Storage and Handling Store
PREGABALIN capsules at room temperature between 20°C to 25°C (68°F to 77°F); [see USP Controlled Room Temperature].
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