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 ImageLabel 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

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