paricalcitol 0.001 MG Oral Capsule
1 INDICATIONS AND USAGE Paricalcitol capsules are a vitamin D analog indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with: Chronic kidney disease (CKD) Stages 3 and 4 (1.1) . CKD Stage 5 in patients on hemodialysis or peritoneal dialysis (1.2) . 1.1 Chronic Kidney Disease Stages 3 and 4 Paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Chronic Kidney Disease Stage 5 Paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD). Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Amneal Pharmaceuticals LLC
OVAL GREY A8
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16 HOW SUPPLIED/STORAGE AND HANDLING
PARICALCITOL capsules, 1 mcg, are supplied as oval, gray soft gelatin capsules imprinted with “A8”. They are available as follows: Bottles of 30: NDC 65162-822-03 Bottles of 90: NDC 65162-822-09
PARICALCITOL capsules, 2 mcg, are supplied as oval, brown soft gelatin capsules imprinted with “A83”. They are available as follows: Bottles of 30: NDC 65162-823-03 Bottles of 90: NDC 65162-823-09
PARICALCITOL capsules, 4 mcg, are supplied as oval, light yellow soft gelatin capsules imprinted with “A84”. They are available as follows: Bottles of 30: NDC 65162-824-03 Bottles of 90: NDC 65162-824-09 Storage Store
PARICALCITOL capsules at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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