Ergocalciferol 1.25 mg Capsule, Liquid Filled, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Provitamin D2 Compound class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Ergocalciferol is used in the treatment of hypoparathyroidism (condition in which the body does not produce enough parathyroid hormone), refractory rickets (softening and weakening of bones that does not respond to treatment), and familial hypophosphatemia (rickets or osteomalacia caused by an inherited condition with a decreased ability to break down vitamin D in the body). Ergocalciferol is in a class of medications called vitamin D analogs. It works by helping the body to use more of the calcium found in foods or supplements.
Read the full MedlinePlus article ↗- It's the same type of vitamin D (vitamin D2), but at much higher doses. The over-the-counter supplements you see on store shelves are for general wellness, while this prescription...
- Is this the same vitamin D I can buy at the pharmacy without a prescription?
- Because the line between a helpful dose and a harmful one is very narrow with ergocalciferol. Too much vitamin D raises your calcium levels to dangerous heights, which can damage y...
- Why does my doctor keep ordering blood tests while I'm on this medication?
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Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 241ATL177A
Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.114 | $11.36 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | $1.25 | $125.34 / 100 capsules |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ergocalciferol 1.25 mg 13668-0757-01 | Torrent | 100 capsules | $0.114 | AA | Availability likely | — |
| Ergocalciferol Capsules, 1.25 mg 42806-0547-01 | Epic | 100 capsules | $0.114 | AA | Availability likely | — |
| Vitamin D 1.25 mg 50268-0297-15 | AvPAK | 50 capsules | $0.114 | AA | Availability likely | — |
| Ergocalciferol 1.25 mg 62135-0439-90 | Chartwell | 90 capsules | $0.114 | AA | Availability likely | — |
| Vitamin D 1.25 mg 64380-0737-06 | Strides | 100 capsules | $0.114 | AA | Availability likely | — |
| Ergocalciferol 1.25 mgthis 69452-0151-20 | Bionpharma | 100 capsules | $0.114 | AA | Availability likely | — |
| Ergocalciferol 1.25 mg 42291-0266-01 | AvKARE | 100 capsules | — | AA | FDA listed | — |
| Ergocalciferol 1.25 mg 43063-0711-12 | PD-Rx | 12 capsules | — | AA | FDA listed | — |
| Ergocalciferol 1.25 mg 43353-0238-03 | Aphena | 3 capsules | — | AA | FDA listed | — |
| Ergocalciferol 1.25 mg 50090-5844-01 | A-S | 8 capsules | — | AA | FDA listed | — |
| Vitamin D 1.25 mg 51407-0700-01 | Golden | 100 capsules | — | AA | FDA listed | — |
| Ergocalciferol Capsules, 1.25 mg 51655-0730-80 | Northwind | 8 capsules | — | AA | FDA listed | — |
| Vitamin D 1.25 mg 51655-0774-27 | Northwind | 12 capsules | — | AA | FDA listed | — |
| Ergocalciferol 1.25 mg 60760-0152-12 | St. | 12 capsules | — | AA | FDA listed | — |
| Vitamin D 1.25 mg 61919-0702-04 | DirectRX | 4 capsules | — | AA | FDA listed | — |
| Vitamin D 1.25 mg 63187-0519-06 | Proficient | 6 capsules | — | AA | FDA listed | — |
| Ergocalciferol 1.25 mg 63629-2447-01 | Bryant | 100 capsules | — | AA | FDA listed | — |
| Ergocalciferol 1.25 mg 63629-7913-01 | Bryant | 90 capsules | — | AA | FDA listed | — |
| Ergocalciferol 1.25 mg 68071-1951-02 | NuCare | 12 capsules | — | AA | FDA listed | — |
| Ergocalciferol 1.25 mg 68071-2295-01 | NuCare | 100 capsules | — | AA | FDA listed | — |
| Ergocalciferol Capsules, 1.25 mg 68788-4042-01 | Preferred | 100 capsules | — | AA | FDA listed | — |
| Ergocalciferol 1.25 mg 68788-4092-01 | Preferred | 100 capsules | — | AA | FDA listed | — |
| Vitamin D 1.25 mg 68788-7627-01 | Preferred | 100 capsules | — | AA | FDA listed | — |
| Ergocalciferol 1.25 mg 70518-0177-03 | REMEDYREPACK | 1 capsule | — | AA | Discontinued | — |
| Vitamin D 1.25 mg 70518-1878-01 | REMEDYREPACK | 12 capsules | — | AA | FDA listed | — |
| Ergocalciferol Capsules, 1.25 mg 70518-3472-00 | REMEDYREPACK | 4 capsules | — | AA | Discontinued | — |
| Ergocalciferol Capsules, 1.25 mg 71205-0676-30 | Proficient | 30 capsules | — | AA | FDA listed | — |
| Ergocalciferol 1.25 mg 71335-0062-00 | Bryant | 45 capsules | — | AA | FDA listed | — |
| Vitamin D 1.25 mg 71335-0278-00 | Bryant | 45 capsules | — | AA | FDA listed | — |
| Ergocalciferol 1.25 mg 71335-1691-00 | Bryant | 45 capsules | — | AA | FDA listed | — |
| Ergocalciferol 1.25 mg 71335-1699-01 | Bryant | 90 capsules | — | AA | FDA listed | — |
| Ergocalciferol Capsules, 1.25 mg 71335-2003-01 | Bryant | 4 capsules | — | AA | FDA listed | — |
| Ergocalciferol 1.25 mg 71335-2246-01 | Bryant | 4 capsules | — | AA | FDA listed | — |
| Vitamin D 1.25 mg 71610-0552-04 | Aphena | 4 capsules | — | AA | FDA listed | — |
| Ergocalciferol 1.25 mg 71610-0712-03 | Aphena | 3 capsules | — | AA | FDA listed | — |
| Vitamin D 1.25 mg 72789-0249-01 | PD-Rx | 100 capsules | — | AA | FDA listed | — |
| Ergocalciferol (Vitamin D2) 1.25 mg 80425-0130-03 | Advanced | 12 capsules | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69452-0151-20 You're viewing this | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-151-20) | 2016-06-15 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
⏱️ Dosage and Administration ▾
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 phosphorous 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 ▾
CONTRAINDICATIONS Ergocalciferol is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
⚠️ Warnings ▾
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 ▾
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. To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.
🔄 Drug Interactions ▾
Drug Interactions Mineral oil interferes with the absorption of fat-soluble vitamins, including vitamin D preparations. Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with ergocalciferol may cause hypercalcemia.
🤰 Pregnancy ▾
Pregnancy Category C Animal reproduction studies have shown fetal abnormalities in several species associated with hypervitaminosis D. These are similar to the supravalvular aortic stenosis syndrome described in infants by Black in England (1963). This syndrome was characterized by supravalvular aortic stenosis, elfin facies, and mental retardation.
For the protection of the fetus, therefore, the use of vitamin D in excess of the recommended dietary allowance during normal pregnancy should be avoided unless, in the judgment of the physician, potential benefits in a specific, unique case outweigh the significant hazards involved. The safety in excess of 400 USP units of vitamin D daily during pregnancy has not been established.
🧒 Pediatric Use ▾
Pediatric Use Pediatric doses must be individualized (see DOSAGE AND ADMINISTRATION ).
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of Ergocalciferol capsules, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. A few published reports have suggested that the absorption of orally administered vitamin D may be attenuated in elderly compared to younger individuals.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
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 in 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 LD 50 in animals is unknown.
The toxic oral dose of ergocalciferol in the dog is 4 mg/kg.
🧬 Clinical Pharmacology ▾
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-dihydroxyvitamin D). Vitamin D metabolites promote the active absorption of calcium and phosphorous 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.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Each green, oval softgel is imprinted with PA140 and contains 1,250 mcg (50,000 USP units vitamin D) of ergocalciferol, USP, and is available in bottles of 100 (NDC 69452-151-20) Softgels. Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP. Manufactured for: Bionpharma Inc. Princeton, NJ 08540, USA MADE IN INDIA Rev.
08/2024 Code: TN/DRUGS/TN00002124 2411295
📋 Description ▾
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 D 2 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 D 2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2 is equal to 40 IU.
Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2 , is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 β ,5 Z ,7 E ,22 E )-; (C 28 H 44 O) with a molecular weight of 396.65, and has the following structural formula: Inactive Ingredients : Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1. Structure Formula