Label: VITAMIN D- ergocalciferol capsule

  • NDC Code(s): 64380-737-06, 64380-737-25
  • Packager: Strides Pharma Science Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 10, 2025

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  • DESCRIPTION
    Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly ...
  • CLINICAL PHARMACOLOGY
    The in vivo synthesis of the major biologically active metabolites of vitamin D occurs in two steps. The first hydroxylation of ergocalciferol takes place in the liver (to 25-hydroxyvitamin D ...
  • INDICATIONS AND USAGE
    Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
  • CONTRAINDICATIONS
    Ergocalciferol Capsules, USP are contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
  • WARNINGS
    Hypersensitivity to vitamin D may be one etiologic factor in infants with idiopathic hypercalcemia. In these cases vitamin D must be strictly restricted. Keep out of the reach of children.
  • PRECAUTIONS
    General - Vitamin D administration from fortified foods, dietary supplements, self-administered and prescription drug sources should be evaluated. Therapeutic dosage should be readjusted as soon ...
  • ADVERSE REACTIONS
    Hypervitaminosis D is characterized by effects on the following organ system: Renal: Impairment of renal function with polyuria, nocturia, polydipsia, hypercalciuria, reversible azotemia ...
  • OVERDOSAGE
    The effects of administered vitamin D can persist for two or more months after cessation of treatment. Hypervitaminosis D is characterized by: Hypercalcemia with anorexia, nausea, weakness ...
  • DOSAGE AND ADMINISTRATION
    THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW. Vitamin D Resistant Rickets: 12,000 to 500,000 USP Units daily. Hypoparathyroidism: 50,000 to 200,000 USP Units daily concomitantly with ...
  • HOW SUPPLIED
    Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units. The green colored oval shaped transparent soft gelatin capsules are imprinted with '194' in white and ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Bottle of 100 capsules - Strides Pharma Inc - Rx only - NDC 64380-737-06 - Vitamin D - (Ergocalciferol Capsules, USP) 1.25 mg* (50,000 USP Units) WARNING: DO NOT EXCEED - RECOMMENDED ...
  • INGREDIENTS AND APPEARANCE
    Product Information