pregabalin 50 mg
1 INDICATIONS AND USAGE Pregabalin capsule is 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 capsule is 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)
alembic pharmaceuticals inc.
CAPSULE RED A 141
A 141 CAPSULE RED
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pregabalin 50 mg
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16 HOW SUPPLIED/STORAGE AND HANDLING
PREGABALIN capsules are available containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg of
PREGABALIN, USP. 25 mg capsules are opaque white/opaque white, size ‘4’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘140’ on body with black ink, filled with white to off-white powder. NDC 62332-119-30 bottle of 30 capsules NDC 62332-119-90 bottle of 90 capsules NDC 62332-119-91 bottle of 1000 capsules NDC 62332-119-10 carton of 100 (10 x 10) unit-dose capsules 50 mg capsules are opaque white/opaque orange, size ‘2’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘141’ on body with black ink, filled with white to off-white powder. NDC 62332-120-30 bottle of 30 capsules NDC 62332-120-90 bottle of 90 capsules NDC 62332-120-91 bottle of 1000 capsules NDC 62332-120-10 carton of 100 (10 x 10) unit-dose capsules 75 mg capsules are opaque white/orange opaque, size ‘4’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘142’ on body with black ink, filled with white to off-white powder. NDC 62332-121-30 bottle of 30 capsules NDC 62332-121-90 bottle of 90 capsules NDC 62332-121-91 bottle of 1000 capsules NDC 62332-121-10 carton of 100 (10 x 10) unit-dose capsules 100 mg capsules are orange opaque/orange opaque, size ‘3’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘143’ on body with black ink, filled with white to off-white powder. NDC 62332-122-30 bottle of 30 capsules NDC 62332-122-90 bottle of 90 capsules NDC 62332-122-91 bottle of 1000 capsules NDC 62332-122-10 carton of 100 (10 x 10) unit-dose capsules 150 mg capsules are opaque white/opaque white, size ‘2’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘144’ on body with black ink, filled with white to off-white powder. NDC 62332-123-30 bottle of 30 capsules NDC 62332-123-90 bottle of 90 capsules NDC 62332-123-91 bottle of 1000 capsules NDC 62332-123-10 carton of 100 (10 x 10) unit-dose capsules 200 mg capsules are orange/orange, size ‘1’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘145’ on body with black ink, filled with white to off-white powder. NDC 62332-124-30 bottle of 30 capsules NDC 62332-124-90 bottle of 90 capsules NDC 62332-124-91 bottle of 1000 capsules NDC 62332-124-10 carton of 100 (10 x 10) unit-dose capsules 225 mg capsules are opaque white/light orange, size ‘1’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘146’ on body with black ink, filled with white to off-white powder. NDC 62332-125-30 bottle of 30 capsules NDC 62332-125-90 bottle of 90 capsules NDC 62332-125-91 bottle of 1000 capsules NDC 62332-125-10 carton of 100 (10 x 10) unit-dose capsules 300 mg capsules are opaque white/orange, size ‘0’, hard gelatin capsules, radially imprinted with ‘A’ on Cap and ‘147’ on body with black ink, filled with white to off-white powder. NDC 62332-126-30 bottle of 30 capsules NDC 62332-126-90 bottle of 90 capsules NDC 62332-126-71 bottle of 500 capsules NDC 62332-126-10 carton of 100 (10 x 10) unit-dose capsules 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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