Drug Catalog - Product Detail
VITAMIN D2 1.25MG CAP 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 69452-0151-20 | BIONPHARMA | 100 | 1.25 MG(50000 UT) | CAPSULE |
PACKAGE FILES
Generic Name
ERGOCALCIFEROL
Substance Name
ERGOCALCIFEROL
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA080704
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
How Supplied
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
Indications & 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.