NDC 66336-907 Ergocalciferol

NDC Product Code 66336-907

NDC 66336-907-06

Package Description: 6 CAPSULE in 1 BOTTLE

NDC 66336-907-44

Package Description: 4 CAPSULE in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Ergocalciferol with NDC 66336-907 is a product labeled by Dispensing Solutions, Inc.. The generic name of Ergocalciferol is . The product's dosage form is and is administered via form.

Labeler Name: Dispensing Solutions, Inc.

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • SOYBEAN OIL (UNII: 241ATL177A)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dispensing Solutions, Inc.
Labeler Code: 66336
Start Marketing Date: 08-17-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Ergocalciferol

Ergocalciferol is pronounced as (er" goe kal sif' er ol)

Why is ergocalciferol medication prescribed?
Ergocalciferol is used in the treatment of hypoparathyroidism (condition in which the body does not produce enough parathyroid hormone), refractory rickets (softening and...
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Ergocalciferol Product Label Images

Ergocalciferol Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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Rx Only

Manufactured by: Swiss Caps AGKirchberg, SwitzerlandDistributed by: Breckenridge Pharmaceutical, Inc.Boca Raton, FL 33487Rev. 04/09

Description

Ergocalciferol Capsules, USP is a synthetic calcium regulator for oral administration.Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity.There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity.One USP Unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 IU.Each softgel capsule, for oral administration, contains Ergocalciferol, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil.Ergocalciferol, also called vitamin D2 ,is 9, 10-secoergosta-5, 7,10(19),22-tetraen-3-ol,(3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula: Chemical StructureInactive Ingredients: D and C Yellow #10, FD and C Blue #1, Gelatin, Glycerin, Purified Water, Refined Soybean Oil.

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) and the second in the kidneys (to
1,25-dihydroxy- vitamin D). Vitamin D metabolites promote the active
absorption of calcium and phosphorus by the small intestine, thus
elevating serum calcium and phosphate levels sufficiently to permit
bone mineralization. Vitamin D metabolites also mobilize calcium and
phosphate from bone and probably increase the reabsorption of calcium
and perhaps also of phosphate by the renal tubules.There is a
time lag of 10 to 24 hours between the administration of vitamin D and
the initiation of its action in the body due to the necessity of
synthesis of the active metabolites in the liver and kidneys.
Parathyroid hormone is responsible for the regulation of this
metabolism in the kidneys.

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.

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.

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, weight loss, vague aches and
  • Stiffness, constipation, mental retardation, anemia, and mild acidosis.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. Widespread calcification of the soft
  • Tissues, including the heart, blood vessels, renal tubules, and lungs.
  • 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).The
  • Treatment of hypervitaminosis D with hypercalcemia consists of
  • Immediate withdrawal of the vitamin, a low calcium diet, generous
  • Intake of fluids, along with symptomatic and supportive treatment.
  • Hypercalcemic crisis with dehydration, stupor, coma, and azotemia
  • Requires more vigorous treatment. The first step should be hydration of
  • The patient. Intravenous saline may quickly and significantly increase
  • Urinary calcium excretion. A loop diuretic (furosemide or ethacrynic
  • Acid) may be given with the saline infusion to further increase renal
  • Calcium excretion. Other reported therapeutic measures include dialysis
  • Or the administration of citrates, sulfates, phosphates,
  • Corticosteroids, EDTA (ethylenediaminetetraacetic acid), and
  • Mithramycin via appropriate regimens. With appropriate therapy,
  • Recovery is the usual outcome when no permanent damage has occurred.
  • Deaths via renal or cardiovascular failure have been reported.The LD50 in animals is unknown. The toxic oral dose of ergocalciferol in the dog is 4 mg/kg.

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 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

Each green, oval softgel capsule is imprinted with A3 and contains 1.25 mg (50,000 USP units vitamin D) of ergocalciferol, USP.Bottles of 100 Softgel Capsules (NDC 51991-604-01).

Storage And Handling

Store at 20°– 25°C (68°–77°F) [See USP Controlled Room Temperature].Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP.

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