Vitafol Fe Plus Capsule, Liquid Filled
NDC Package 0642-7473-30

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

Package Information

Vitafol Fe Plus (doconexent, niacinamide, .alpha.-tocopherol acetate, dl-, cholecalciferol, beta carotene, ascorbic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, iron, zinc oxide, cupric oxide, potassium iodide, magnesium oxide, folic acid, and levomefolate calcium) capsules is vitafol® Fe+ prenatal supplement is contraindicated in patients with hypersensitivity to any of its components or color additives.Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.Iron supplementation is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B12). This formulation utilizes a capsule, liquid filled delivery system. Marketed by Exeltis Usa, Inc., this product is identified by NDC 0642-7473.

Identification & Billing

NDC Package Code
0642-7473-30
Package Description
5 BLISTER PACK in 1 BOX, UNIT-DOSE / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code
0642-7473
11-Digit Billing Format
00642747330
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
5 EA

Clinical Specifications

Proprietary Name
Vitafol Fe Plus
Non-Proprietary Name
Doconexent, Niacinamide, .alpha.-tocopherol Acetate, Dl-, Cholecalciferol, Beta Carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, And Levomefolate Calcium
Substance Name
.alpha.-tocopherol Acetate, Dl-; Ascorbic Acid; Beta Carotene; Cholecalciferol; Cupric Oxide; Cyanocobalamin; Doconexent; Folic Acid; Iron; Levomefolate Calcium; Magnesium Oxide; Niacinamide; Potassium Iodide; Pyridoxine Hydrochloride; Riboflavin; Thiamine Mononitrate; Zinc Oxide
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Vitafol® Fe+ prenatal supplement is contraindicated in patients with hypersensitivity to any of its components or color additives.Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.Iron supplementation is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B12).

Regulatory & Marketing

Labeler Name
Exeltis Usa, Inc.
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
03-15-2020
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 0642-7473-30 identifies a specific commercial package of 5 blister pack in 1 box, unit-dose / 6 capsule, liquid filled in 1 blister pack of Vitafol Fe Plus, a human prescription drug labeled by Exeltis Usa, Inc.. This capsule, liquid filled is formulated for oral use and contains .alpha.-tocopherol acetate, dl-; ascorbic acid; beta carotene; cholecalciferol; cupric oxide; cyanocobalamin; doconexent; folic acid; iron; levomefolate calcium; magnesium oxide; niacinamide; potassium iodide; pyridoxine hydrochloride; riboflavin; thiamine mononitrate; zinc 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 Exeltis Usa, Inc. on March 15, 2020. The current certification is valid through December 31, 2026.

How is this Exeltis Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00642747330. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 5 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 (4-4-2)
0642-7473-30
11-Digit CMS (5-4-2)
00642-7473-30

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