RVP

Drug Catalog - Product Detail

ORTHO D CAPS 1MG/3775IU 30CT

NDC Mfr Size Str Form
69499-0301-30 SOLUBIOMIX LLC 30 1-3775MG-UNIT NA
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Description
DESCRIPTION: Ortho D Capsules is an orally administered prescription folate product for the dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency and other nutritional supplementation. Ortho D should be administered under the supervision of a licensed medical practitioner. Vitamin D3 (cholecalciferol) is a white, crystalline powder, very soluble in water, with the following structural formula:]: Each capsule contains: Folic Acid ............................................................................1 mg Vitamin D3 (Cholecalciferol) .............................................3775 IU Each capsule contains the following inactive ingredients: Gelatin, cellulose, magnesium stearate, silica. image description
How Supplied
HOW SUPPLIED: Ortho D capsules are supplied as clear capsules printed with “301” dispensed in child-resistant bottles of 30ct (69499-301-30*). * This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) – or similarly-formatted product code, as required by pedigree reporting requirements and supply-chain control as well as – in some cases, for insurance-reimbursement applications. All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.
Indications & Usage
INDICATIONS AND USAGE: Ortho D is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D deficiency or are in need of Vitamin D supplementation and other nutritional supplementation. Ortho D can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.
Dosage and Administration
DOSAGE AND ADMINISTRATION: Take one capsule daily or as directed by a healthcare practitioner.