Vitafol Capsule, Gelatin Coated
NDC Package 0642-0070-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Vitafol (prenatal supplement with dha) capsules is a medication a multivitamin product used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, or during pregnancy. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Exeltis Usa, Inc., this product is identified by NDC 0642-0070.

Identification & Billing

NDC Package Code
0642-0070-01
Package Description
1 BLISTER PACK in 1 BOX / 4 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Product Code
11-Digit Billing Format
00642007001
RxNorm Crosswalk
  • RxCUI: 1119569 - ascorbic acid 30 MG / cholecalciferol 1000 UNT / cuprous oxide 2 MG / folic acid 1 MG / magnesium oxide 20 MG / niacin 15 MG / polysaccharide iron complex 29 MG / potassium iodide 0.15 MG / pyridoxine hydrochloride 2.5 MG / riboflavin 1.8 MG / thiamine mononitrate 1.6 MG / vitamin A 1100 UNT / vitamin B12 0.012 MG / vitamin E 20 UNT / zinc oxide 25 MG Oral Capsule
  • RxCUI: 1119569 - vitamin C 30 MG / cholecalciferol 1000 UNT / cuprous oxide 2 MG / folate 1 MG / magnesium oxide 20 MG / nicotinic acid 15 MG / polysaccharide iron complex 29 MG / K+ iodide 0.15 MG / vitamin B6 hydrochloride 2.5 MG / riboflavin 1.8 MG / vitamin B1 mononitrate 1.6 MG / vitamin A 1100 UNT / vitamin B12 0.012 MG / vitamin E 20 UNT / ZNO 25 MG Oral Capsule
  • RxCUI: 1119569 - vitamin C 30 MG / cholecalciferol 1000 UNT / cuprous oxide 2 MG / folate 1 MG / magnesium oxide 20 MG / nicotinic acid 15 MG / polysaccharide iron complex 29 MG / K+ iodide 0.15 MG / vitamin B6 hydrochloride 2.5 MG / riboflavin 1.8 MG / vit-B1 mononitrate 1.6 MG / vitamin A 1100 UNT / vitamin B12 0.012 MG / vitamin E 20 UNT / ZNO 25 MG Oral Capsule
  • RxCUI: 1119569 - vitamin C 30 MG / cholecalciferol 1000 UNT / cuprous oxide 2 MG / folate 1 MG / magnesium oxide 20 MG / nicotinic acid 15 MG / polysaccharide iron complex 29 MG / K+ iodide 0.15 MG / vit-B6 hydrochloride 2.5 MG / riboflavin 1.8 MG / vitamin B1 mononitrate 1.6 MG / vitamin A 1100 UNT / vitamin B12 0.012 MG / vitamin E 20 UNT / ZNO 25 MG Oral Capsule
  • RxCUI: 1119569 - vitamin C 30 MG / cholecalciferol 1000 UNT / cuprous oxide 2 MG / folate 1 MG / magnesium oxide 20 MG / nicotinic acid 15 MG / polysaccharide iron complex 29 MG / K+ iodide 0.15 MG / vit-B6 hydrochloride 2.5 MG / riboflavin 1.8 MG / vit-B1 mononitrate 1.6 MG / vitamin A 1100 UNT / vitamin B12 0.012 MG / vitamin E 20 UNT / ZNO 25 MG Oral Capsule

Clinical Specifications

Proprietary Name
Vitafol One
Non-Proprietary Name
Prenatal Supplement With Dha
Substance Name
.alpha.-tocopherol; Ascorbic Acid; Copper; Cyanocobalamin; Folic Acid; Iodine; Iron; Magnesium; Niacin; Omega-3 Fatty Acids; Pyridoxine Hydrochloride; Riboflavin; Thiamine Mononitrate; Vitamin A; Vitamin D; Zinc
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.
Usage Information
This medication is a multivitamin product used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, or during pregnancy. Vitamins are important building blocks of the body and help keep you in good health.

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
06-13-2011
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0642-0070). Click a package code to view its specific billing and regulatory data.

1 BLISTER PACK in 1 BOX / 3 CAPSULE, GELATIN COATED in 1 BLISTER PACK
5 BLISTER PACK in 1 BOX / 6 CAPSULE, GELATIN COATED in 1 BLISTER PACK

* 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 0642-0070-01 identifies a specific commercial package of 1 blister pack in 1 box / 4 capsule, gelatin coated in 1 blister pack of Vitafol One, a human prescription drug labeled by Exeltis Usa, Inc.. This capsule, gelatin coated is formulated for oral use and contains .alpha.-tocopherol; ascorbic acid; copper; cyanocobalamin; folic acid; iodine; iron; magnesium; niacin; omega-3 fatty acids; pyridoxine hydrochloride; riboflavin; thiamine mononitrate; vitamin a; vitamin d; zinc 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 June 13, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is a multivitamin product used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, or during pregnancy. Vitamins are important building blocks of the body and help keep you in good health.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00642007001. 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)
0642-0070-01
11-Digit CMS (5-4-2)
00642-0070-01

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