mycophenolate mofetil 250 mg
1 INDICATIONS AND USAGE Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. ( 1 ) Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1) ] , heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ], in combination with other immunosuppressants.
Lupin Pharmaceuticals, Inc.
CAPSULE BLUE C3 250
C3 250 CAPSULE BLUE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Handling and Disposal Mycophenolate mofetil, USP (MMF) has demonstrated teratogenic effects in humans [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Mycophenolate mofetil tablets, USP should not be crushed and mycophenolate mofetil capsules, USP should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in Mycophenolate mofetil capsules, USP [see Dosage and Administration (2.6)]. Follow applicable special handling and disposal procedures 1 . 16.2 Mycophenolate mofetil capsules USP 250 mg capsules: white to off white granular powder filled in size '1' hard gelatin capsule with opaque blue cap imprinted "C3 250" and opaque brown body. Sizes Bottle of 100 NDC 70748-186-01 Bottle of 500 NDC 70748-186-02 Storage: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) 16.3 Mycophenolate mofetil tablets USP 500 mg Tablets: : Lavender-colored, caplet-shaped, film coated tablets, debossed with "C4" on one side and plain on the other side Sizes Bottle of 100 NDC 70748-262-01 Bottle of 500 NDC 70748-262-02 Storage and Dispensing Information: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in light-resistant containers, such as the manufacturer's original containers.
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