pregabalin 200 MG Oral Capsule
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 )
camber pharmaceuticals, inc.
CAPSULE ORANGE 143 J
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16 HOW SUPPLIED/STORAGE AND HANDLING 25 mg capsules: white cap / white body size '4' hard gelatin capsules imprinted with '138' on cap and 'J' on body with black ink, filled with white to off white powder. Bottle of 60 capsules NDC 31722-610-60 Bottle of 90 capsules NDC 31722-610-90 Bottle of 500 capsules NDC 31722-610-05 Blister Pack of 100 (10x10) Unit-dose capsules (PVC-Alu)* NDC 31722-610-31 Blister Pack of 70 (10x7) Unit-dose capsules (Alu-Alu)# NDC 31722-610-32 50 mg capsules: white cap / white body size '4' hard gelatin capsules imprinted with '139' on cap and 'J' on body with black ink, filled with white to off white powder. Bottle of 60 capsules NDC 31722-611-60 Bottle of 90 capsules NDC 31722-611-90 Bottle of 500 capsules NDC 31722-611-05 Blister Pack of 100 (10x10) Unit-dose capsules (PVC-Alu) NDC 31722-611-31 Blister Pack of 70 (10x7) Unit-dose capsules (Alu-Alu)# NDC 31722-611-32 75 mg capsules: Light peach opaque cap / white opaque body size '4' hard gelatin capsules imprinted with '140' on cap and 'J' on body with black ink, filled with white to off white powder. Bottle of 60 capsules NDC 31722-612-60 Bottle of 90 capsules NDC 31722-612-90 Bottle of 500 capsules NDC 31722-612-05 Blister Pack of 100 (10x10) Unit-dose capsules (PVC-Alu)* NDC 31722-612-31 100 mg capsules: Light peach opaque cap / light peach opaque body size '3' hard gelatin capsules imprinted with '141' on cap and 'J' on body with black ink, filled with white to off white powder. Bottle of 60 capsules NDC 31722-613-60 Bottle of 90 capsules NDC 31722-613-90 Bottle of 500 capsules NDC 31722-613-05 Blister Pack of 100 (10x10) Unit-dose capsules (PVC-Alu) NDC 31722-613-31 150 mg capsules: white cap / white body size '2' hard gelatin capsules imprinted with '142' on cap and 'J' on body with black ink, filled with white to off white powder. Bottle of 60 capsules NDC 31722-614-60 Bottle of 90 capsules NDC 31722-614-90 Bottle of 500 capsules NDC 31722-614-05 Blister Pack of 100 (10x10) Unit-dose capsules (PVC-Alu)* NDC 31722-614-31 200 mg capsules: Light peach opaque cap / light peach opaque body size '1' hard gelatin capsules imprinted with '143' on cap and 'J' on body with black ink, filled with white to off white powder. Bottle of 60 capsules NDC 31722-615-60 Bottle of 90 capsules NDC 31722-615-90 Bottle of 500 capsules NDC 31722-615-05 Blister Pack of 100 (10x10) Unit-dose capsules (PVC-Alu)* NDC 31722-615-31 225 mg capsules: Light peach opaque cap / white opaque body size '1' hard gelatin capsules imprinted with '144' on cap and 'J' on body with black ink, filled with white to off white powder. Bottle of 60 capsules NDC 31722-616-60 Bottle of 90 capsules NDC 31722-616-90 Bottle of 500 capsules NDC 31722-616-05 Blister Pack of 100 (10x10) Unit-dose capsules (PVC-Alu)* NDC 31722-616-31 300 mg capsules: Light peach opaque cap / white opaque body size '0' hard gelatin capsules imprinted with '145' on cap and 'J' on body with black ink, filled with white to off white powder. Bottle of 60 capsules NDC 31722-617-60 Bottle of 90 capsules NDC 31722-617-90 Bottle of 500 capsules NDC 31722-617-05 Blister Pack of 100 (10x10) Unit-dose capsules (PVC-Alu)* NDC 31722-617-31 Blister Pack of 100 (10x10) Unit-dose capsules (Alu-Alu)# NDC 31722-617-32 *PVC-Alu: Polyvinyl Chloride film with Aluminium foil, where forming web is PVC film which has a backing of a lidding seal of aluminum foil. #Alu-Alu: An aluminum-based laminate film, where the forming and lidding material used for blister is Aluminium. Storage and Handling Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].
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