Prenate Elite Tablet, Coated
NDC Package 75854-314-30
Package Information
Prenate Elite (.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, calcium formate, ferrous asparto glycinate, cyanocobalamin, biotin, potassium iodide, magnesium oxide, zinc oxide and cupric oxide) tablets is a medication a multivitamin and iron product used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, or during pregnancy. This formulation utilizes a tablet, coated delivery system. Marketed by Avion Pharmaceuticals, Llc, this product is identified by NDC 75854-314.
Identification & Billing
Clinical Specifications
- .BETA.-CAROTENE 18 mg/1
- ASCORBIC ACID 780 ug/1
- CHOLECALCIFEROL 75 mg/1
- .ALPHA.-TOCOPHEROL ACETATE, DL- 330 ug/1
- THIAMINE MONONITRATE 160 mg/1
- RIBOFLAVIN 15 ug/1
- NIACINAMIDE 1.5 mg/1
- PYRIDOXINE HYDROCHLORIDE 13 ug/1
- FOLIC ACID 20 mg/1
- LEVOMEFOLATE CALCIUM 400 ug/1
- CALCIUM FORMATE 600 ug/1
- FERROUS ASPARTO GLYCINATE 25 mg/1
- CYANOCOBALAMIN 21 mg/1
- BIOTIN 150 ug/1
- POTASSIUM IODIDE 21 mg/1
- MAGNESIUM OXIDE 3.5 mg/1
- ZINC OXIDE 3 mg/1
- CUPRIC OXIDE 15 mg/1
- Analogs/Derivatives - [Chemical/Ingredient]
- Ascorbic Acid - [CS]
- Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
- Calcium - [CS]
- Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
- Cations, Divalent - [CS]
- Copper Absorption Inhibitor - [EPC] (Established Pharmacologic Class)
- Decreased Copper Ion Absorption - [PE] (Physiologic Effect)
- Folate Analog - [EPC] (Established Pharmacologic Class)
- Folic Acid - [CS]
- Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
- Osmotic Activity - [MoA] (Mechanism of Action)
- Osmotic Laxative - [EPC] (Established Pharmacologic Class)
- Phosphate Binder - [EPC] (Established Pharmacologic Class)
- Phosphate Chelating Activity - [MoA] (Mechanism of Action)
- Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
- Vitamin B 12 - [CS]
- Vitamin B 6 - [Chemical/Ingredient]
- Vitamin B12 - [EPC] (Established Pharmacologic Class)
- Vitamin B6 Analog - [EPC] (Established Pharmacologic Class)
- Vitamin C - [EPC] (Established Pharmacologic Class)
- Vitamin D - [CS]
- Vitamin D - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 75854 - Avion Pharmaceuticals, Llc
- 75854-314 - Prenate Elite
- 75854-314-30 - 30 TABLET, COATED in 1 BOTTLE
- 75854-314 - Prenate Elite
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 75854-314-30 identifies a specific commercial package of 30 tablet, coated in 1 bottle of Prenate Elite, a human prescription drug labeled by Avion Pharmaceuticals, Llc. This tablet, coated is formulated for oral use and contains .beta.-carotene; ascorbic acid; cholecalciferol; .alpha.-tocopherol acetate, dl-; thiamine mononitrate; riboflavin; niacinamide; pyridoxine hydrochloride; folic acid; levomefolate calcium; calcium formate; ferrous asparto glycinate; cyanocobalamin; biotin; potassium iodide; magnesium oxide; zinc oxide; cupric oxide as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Avion Pharmaceuticals, Llc on June 05, 2014. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
This medication is a multivitamin and iron product used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, or during pregnancy. Vitamins and iron are important building blocks of the body and help keep you in good health.
How is this Avion Pharmaceuticals, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 75854031430. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.