HECTOROL Capsule / Solution for injection Ref.[10031] Active ingredients: Doxercalciferol

Source: FDA, National Drug Code (US) Revision Year: 2018

Product description

HECTOROL contains doxercalciferol, which is a synthetic vitamin D₂ analog. Doxercalciferol undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D₂ (1α,25-(OH)₂D₂), a naturally occurring, biologically active form of vitamin D₂.

Doxercalciferol is a colorless crystalline compound with a calculated molecular weight of 412.66 and a molecular formula of C₂₈H₄₄O₂. It is soluble in oils and organic solvents, but is relatively insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-1,3-diol. The structural formula is:

Capsules

HECTOROL capsules are soft gelatin capsules containing 0.5 mcg, 1 mcg, or 2.5 mcg doxercalciferol for oral use. Each capsule also contains butylated hydroxyanisole (BHA), ethanol, and fractionated triglyceride of coconut oil. The capsule shells contain gelatin, glycerin, and titanium dioxide. In addition, the 0.5 mcg capsule shells contain yellow iron oxide and FD&C Red No. 40, the 1 mcg capsule shells contain FD&C Yellow No. 6, and the 2.5 mcg capsule shells contain yellow iron oxide.

Injection

HECTOROL injection 1 mL single-dose vials contain 2 mcg/mL of doxercalciferol. HECTOROL injection 2 mL single-dose vials contain 4 mcg/2 mL (2 mcg/mL) of doxercalciferol. Each milliliter (mL) of solution contains 2 mcg doxercalciferol and the following inactive ingredients: butylated hydroxytoluene (0.02 mg); disodium edetate (1.1 mg); ethanol, 100% (0.05 mL); polysorbate 20 (10 mg); sodium chloride (1.5 mg); sodium phosphate dibasic, heptahydrate (14.4 mg); and sodium phosphate monobasic, monohydrate (1.8 mg).

HECTOROL injection 2 mL multiple-dose vials contain 4 mcg/2 mL (2 mcg/mL) of doxercalciferol. Each milliliter (mL) of solution contains 2 mcg doxercalciferol and the following inactive ingredients: butylated hydroxytoluene (0.02 mg); disodium edetate (1.1 mg); ethanol, 100% (0.075 mL); polysorbate 20 (10 mg); sodium chloride (1.5 mg); sodium phosphate dibasic, heptahydrate (14.4 mg); and sodium phosphate monobasic, monohydrate (1.8 mg).

Dosage Forms and Strengths
Capsules: soft gelatin, oval capsules with imprinted “g” available as follows: 0.5 mcg (salmon color) 1 mcg (peach color) 2.5 mcg (butter-yellow color) Injection: clear and colorless solution available as follows: 2 mcg/mL single-dose vial 4 mcg/2 mL (2 mcg/mL) single-dose vial 4 mcg/2 mL (2 mcg/mL) multiple-dose vial

How Supplied

HECTOROL capsules are oval, soft gelatin capsules supplied as follows.

Strength	Capsule Color	Imprint Code	Package size	NDC
0.5 mcg	salmon	g	bottle of 50 capsules	58468-0120-1
1 mcg	peach	g	bottle of 50 capsules	58468-0124-1
2.5 mcg	butter-yellow	g	bottle of 50 capsules	58468-0121-1

HECTOROL injection is a clear, colorless solution supplied in 2 mL amber glass vials as follows.

Total Strength per Total Volume	Strength per mL	Flip-off Cap Color	Vial Count per Carton × Total Vial Volume and Vial Type	Carton NDC	Vial NDC
2 mcg/mL	2 mcg/mL	Green	50 × 1 mL single-dose vials	58468-0126-1	58468-0126-0
4 mcg/2 mL	2 mcg/mL	Yellow	50 × 2 mL single-dose vials	58468-0123-1	58468-0123-0
4 mcg/2 mL	2 mcg/mL	Orange	50 × 2 mL multiple-dose vials	58468-0127-1	58468-0127-0

Drugs

Drug	Countries
HECTOROL	United States

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