Ergocalciferol (Page 2 of 2)

DOSAGE AND ADMINISTRATION

THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.

Vitamin D Resistant Rickets: 12,000 to 500,000 IU units daily.

Hypoparathyroidism: 50,000 to 200,000 IU units daily concomitantly with calcium lactate 4 g, six times per day.

DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.

Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary.

X-rays of the bones should be taken every month until condition is corrected and stabilized.

HOW SUPPLIED

Product: 50090-5844

NDC: 50090-5844-1 8 CAPSULE in a BOTTLE

NDC: 50090-5844-2 4 CAPSULE in a BOTTLE

NDC: 50090-5844-3 12 CAPSULE in a BOTTLE

VITAMIN D(ERGOCALCIFEROL CAPSULES)

Label Image

ERGOCALCIFEROL ergocalciferol capsules, capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-5844(NDC:42806-547) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERGOCALCIFEROL (ERGOCALCIFEROL) ERGOCALCIFEROL 1.25 mg

Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN PROPYLENE GLYCOL SHELLAC DIMETHICONE SOYBEAN OIL TITANIUM DIOXIDE

Product Characteristics Color GREEN (clear-pale yellow solution) Score no score Shape OVAL Size 13mm Flavor Imprint Code PC7 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50090-5844-1 8 CAPSULE in 1 BOTTLE None 2 NDC:50090-5844-2 4 CAPSULE in 1 BOTTLE None 3 NDC:50090-5844-3 12 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204276 12/10/2018

Labeler — A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Operations
A-S Medication Solutions		830016429	RELABEL (50090-5844), REPACK (50090-5844)

Revised: 11/2021 A-S Medication Solutions