Prenate Restore Capsule, Gelatin Coated
NDC Package 75854-308-30

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

Package Information

Prenate Restore (ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent) capsules is iNDICATIONS: PRENATE ® Restore is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women during the postnatal period for both lactating and non-lactating mothers. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Avion Pharmaceuticals, Llc, this product is identified by NDC 75854-308.

Identification & Billing

NDC Package Code
75854-308-30
Package Description
30 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
75854-308
11-Digit Billing Format
75854030830
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 Restore
Non-Proprietary Name
Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Lactic Acid And Doconexent
Substance Name
.alpha.-tocopherol Acetate, Dl-; Ascorbic Acid; Biotin; Calcium Carbonate; Cholecalciferol; Cyanocobalamin; Doconexent; Ferrous Fumarate; Folic Acid; Lactic Acid; Magnesium Oxide; 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
INDICATIONS: PRENATE ® Restore is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women during the postnatal period for both lactating and non-lactating mothers.

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
09-17-2013
Listing Expiration
12-31-2026
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 75854-308-30 identifies a specific commercial package of 30 capsule, gelatin coated in 1 bottle of Prenate Restore, a human prescription drug labeled by Avion Pharmaceuticals, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This capsule, gelatin coated is formulated for oral use and contains .alpha.-tocopherol acetate, dl-; ascorbic acid; biotin; calcium carbonate; cholecalciferol; cyanocobalamin; doconexent; ferrous fumarate; folic acid; lactic acid; magnesium oxide; 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 September 17, 2013. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75854030830. 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)
75854-308-30
11-Digit CMS (5-4-2)
75854-0308-30

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