Ergocalciferol Capsules,

Ergocalciferol Capsules, is an FDA-registered drug product whose active ingredient is ERGOCALCIFEROL CAPSULES,. It is labelled by REMEDYREPACK INC. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 70518-3472, application ANDA204276, label effective 20260810. It is one of 3 FDA drug label records sharing the active ingredient ERGOCALCIFEROL CAPSULES,. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ERGOCALCIFEROL CAPSULES, are most often described in connection with: usage ergocalciferol, treatment hypoparathyroidism, refractory rickets, known vitamin, familial hypophosphatemia. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE Ergocalciferol Capsules are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.

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.

CONTRAINDICATIONS Ergocalciferol Capsules 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.

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, hypertension, nephrocalcinosis, generalized vascular calcification, or irreversible renal insufficiency which may result in death. CNS: Mental retardation. Soft Tissues: Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. Skeletal: Bone demineralization (osteoporosis) in adults occurs concomitantly. Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism) vague aches, stiffness, and weakness. Gastrointestinal: Nausea, anorexia, constipation. Metabolic: Mild acidosis, anemia, weight loss.

FDA lists 3 drug label records with ERGOCALCIFEROL CAPSULES, as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Ergocalciferol Capsules, used for?
INDICATIONS AND USAGE Ergocalciferol Capsules are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.

Who makes Ergocalciferol Capsules,?
REMEDYREPACK INC. is the labeler of record for Ergocalciferol Capsules,. 3 FDA label records share the active ingredient ERGOCALCIFEROL CAPSULES,, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Ergocalciferol Capsules, come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Ergocalciferol Capsules, prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ERGOCALCIFEROL CAPSULES,?
Yes. 3 FDA drug label records list ERGOCALCIFEROL CAPSULES, as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Ergocalciferol Capsules, been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.