Paxlyte Capsule
NDC Package 64661-217-30

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

Package Information

Paxlyte (leucovorin, folic acid, levomefolate magnesium, ferrous cysteine glycinate, 1, 2-docosahexanoyl-sn-glycero-3-phosphoserine calcium, 1, 2-icosapentoyl-sn-glycero-3-phosphoserine calcium, phosphatidyl serine, pyridoxal 5-phosphate, flavin adenine dinucleotide, nadh, cobamamide, cocarboxylase (thiamine pyrophosphate), magnesium ascorbate, zinc ascorbate, magnesium l-threonate and betaine capsule) capsules is classified as a

administered via oral route. This formulation utilizes a capsule delivery system. Marketed by Jaymac Pharmaceuticals, this product is identified by NDC 64661-217.

Identification & Billing

NDC Package Code
64661-217-30
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
64661-217
11-Digit Billing Format
64661021730
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
Paxlyte
Non-Proprietary Name
Leucovorin, Folic Acid, Levomefolate Magnesium, Ferrous Cysteine Glycinate, 1, 2-docosahexanoyl-sn-glycero-3-phosphoserine Calcium, 1, 2-icosapentoyl-sn-glycero-3-phosphoserine Calcium, Phosphatidyl Serine, Pyridoxal 5-phosphate, Flavin Adenine Dinucleotide, Nadh, Cobamamide, Cocarboxylase (thiamine Pyrophosphate), Magnesium Ascorbate, Zinc Ascorbate, Magnesium L-threonate And Betaine Capsule
Substance Name
1,2-docosahexanoyl-sn-glycero-3-phosphoserine Calcium; 1,2-icosapentoyl-sn-glycero-3-phosphoserine Calcium; Betaine; Citric Acid Monohydrate; Cobamamide; Cocarboxylase; Ferrous Cysteine Glycinate; Flavin Adenine Dinucleotide; Folic Acid; Leucovorin; Levomefolate Magnesium; Magnesium Ascorbate; Magnesium L-threonate; Nadh; Phosphatidyl Serine; Pyridoxal Phosphate Anhydrous; Sodium Citrate; Zinc Ascorbate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Jaymac Pharmaceuticals
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
08-01-2024
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 64661-217-30 identifies a specific commercial package of 30 capsule in 1 bottle of Paxlyte, a human prescription drug labeled by Jaymac Pharmaceuticals. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This capsule is formulated for oral use and contains 1,2-docosahexanoyl-sn-glycero-3-phosphoserine calcium; 1,2-icosapentoyl-sn-glycero-3-phosphoserine calcium; betaine; citric acid monohydrate; cobamamide; cocarboxylase; ferrous cysteine glycinate; flavin adenine dinucleotide; folic acid; leucovorin; levomefolate magnesium; magnesium ascorbate; magnesium l-threonate; nadh; phosphatidyl serine; pyridoxal phosphate anhydrous; sodium citrate; zinc ascorbate 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 Jaymac Pharmaceuticals on August 01, 2024. The current certification is valid through December 31, 2026.

How is this Jaymac Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64661021730. 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)
64661-217-30
11-Digit CMS (5-4-2)
64661-0217-30

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