Prenate Essential Capsule, Gelatin Coated
NDC Package 75854-313-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Prenate Essential (ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent) capsules is this medication contains vitamins, minerals, and fatty acids. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Avion Pharmaceuticals, Llc, this product is identified by NDC 75854-313.

Identification & Billing

NDC Package Code
75854-313-30
Package Description
30 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
75854-313
11-Digit Billing Format
75854031330
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Prenate Essential
Non-Proprietary Name
Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Pyridoxine Hydrochloride, Folic Acid, 5-methyltetrahydrofolic Acid, Cyanocobalamin, Biotin, Calcium Formate, Ferrous Asparto Glycinate, Potassium Iodide, Magnesium Oxide, Doconexent And Icosapent
Substance Name
.alpha.-tocopherol Acetate, Dl-; 5-methyltetrahydrofolic Acid; Ascorbic Acid; Biotin; Calcium Formate; Cholecalciferol; Cyanocobalamin; Doconexent; Ferrous Asparto Glycinate; Folic Acid; Icosapent; Magnesium Oxide; Potassium Iodide; Pyridoxine Hydrochloride
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This medication contains vitamins, minerals, and fatty acids. It is used to treat or prevent a lack of these nutrients during pregnancy or due to poor diet or certain illnesses. Vitamins, minerals, and fatty acids are important building blocks of the body and help keep you in good health. This combination product may contain folic acid. Women who are or may become pregnant should maintain adequate levels of folic acid through either diet or supplements to prevent spinal cord birth defects. Some supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use. The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

Regulatory & Marketing

Labeler Name
Avion Pharmaceuticals, Llc
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
07-18-2014
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 75854-313-30 identifies a specific commercial package of 30 capsule, gelatin coated in 1 bottle of Prenate Essential, a human prescription drug labeled by Avion Pharmaceuticals, Llc. This capsule, gelatin coated is formulated for oral use and contains .alpha.-tocopherol acetate, dl-; 5-methyltetrahydrofolic acid; ascorbic acid; biotin; calcium formate; cholecalciferol; cyanocobalamin; doconexent; ferrous asparto glycinate; folic acid; icosapent; magnesium oxide; potassium iodide; pyridoxine hydrochloride 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 July 18, 2014. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication contains vitamins, minerals, and fatty acids. It is used to treat or prevent a lack of these nutrients during pregnancy or due to poor diet or certain illnesses. Vitamins, minerals, and fatty acids are important building blocks of the body and help keep you in good health. This combination product may contain folic acid. Women who are or may become pregnant should maintain adequate levels of folic acid through either diet or supplements to prevent spinal cord birth defects. Some supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use. The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

How is this Avion Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75854031330. 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:

10-Digit Format (5-3-2)
75854-313-30
11-Digit CMS (5-4-2)
75854-0313-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.