Source: FDA, National Drug Code (US) Revision Year: 2021
Calcifediol, USP, the active ingredient in RAYALDEE, is synthetically manufactured as calcifediol monohydrate. Calcifediol is also known as calcidiol, 25-hydroxycholecalciferol or 25-hydroxyvitamin D3.
Calcifediol monohydrate is a white crystalline powder, has a calculated molecular weight of 418.65 and is soluble in alcohol and fatty oils but practically insoluble in water. Chemically, calcifediol monohydrate is (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-3,25-diol monohydrate and its structural formula is:
RAYALDEE is formulated as extended-release capsules containing 30 mcg of calcifediol. Each capsule contains the following excipients: mineral oil, monoglycerides and diglycerides, paraffin, hypromellose, lauroyl polyoxylglycerides, dehydrated alcohol and butylated hydroxytoluene. The capsule shells contain modified starch, carrageenan, sodium phosphate, dibasic, sorbitol sorbitan solution, FD&C Blue #1, titanium dioxide and purified water. Medium chain triglyceride (fractionated coconut) oil is used as a lubricant during manufacture, and trace amounts may be present in the final formulation.
| Dosage Forms and Strengths |
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RAYALDEE 30 mcg extended-release capsules are blue oval soft capsules labeled with “O” in white ink. |
| How Supplied |
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RAYALDEE is supplied as 30 mcg calcifediol in blue, oval extended-release capsules, imprinted O: Bottles of 30 [NDC 70301-1001-1] Bottles of 60 [NDC 70301-1001-2] Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Manufactured for: OPKO Pharmaceuticals, LLC, 4400 Biscayne Blvd., Miami FL 33137 USA |
| Drug | Countries | |
|---|---|---|
| RAYALDEE | Ireland, United States |
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