Paxlyte Capsule
NDC Package 64661-217-30
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
- acidifying activity - [moa] (mechanism of action)
- anti-coagulant - [epc] (established pharmacologic class)
- ascorbic acid - [cs]
- calcium chelating activity - [moa] (mechanism of action)
- calculi dissolution agent - [epc] (established pharmacologic class)
- decreased coagulation factor activity - [pe] (physiologic effect)
- folate analog - [epc] (established pharmacologic class)
- folic acid - [cs]
- increased large intestinal motility - [pe] (physiologic effect)
- inhibition large intestine fluid/electrolyte absorption - [pe] (physiologic effect)
- methylating activity - [moa] (mechanism of action)
- methylating agent - [epc] (established pharmacologic class)
- osmotic activity - [moa] (mechanism of action)
- osmotic laxative - [epc] (established pharmacologic class)
- vitamin c - [epc] (established pharmacologic class)
Identification & Billing
Clinical Specifications
- LEUCOVORIN 6.4 mg/1
- FOLIC ACID 800 ug/1
- LEVOMEFOLATE MAGNESIUM 500 mg/1
- FERROUS CYSTEINE GLYCINATE 1.83 mg/1
- 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 50 ug/1
- 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 25 ug/1
- PHOSPHATIDYL SERINE 13.6 mg/1
- PYRIDOXAL PHOSPHATE ANHYDROUS 25 ug/1
- FLAVIN ADENINE DINUCLEOTIDE 1 mg/1
- NADH 2.5 mg/1
- COBAMAMIDE 7 mg/1
- COCARBOXYLASE 24 mg/1
- MAGNESIUM ASCORBATE 1 mg/1
- ZINC ASCORBATE 25 ug/1
- MAGNESIUM L-THREONATE 12 mg/1
- BETAINE 25 ug/1
- CITRIC ACID MONOHYDRATE 1.83 mg/1
- SODIUM CITRATE 1 mg/1
- Acidifying Activity - [MoA] (Mechanism of Action)
- Anti-coagulant - [EPC] (Established Pharmacologic Class)
- Ascorbic Acid - [CS]
- Calcium Chelating Activity - [MoA] (Mechanism of Action)
- Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
- Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
- Folate Analog - [EPC] (Established Pharmacologic Class)
- Folic Acid - [CS]
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Methylating Activity - [MoA] (Mechanism of Action)
- Methylating Agent - [EPC] (Established Pharmacologic Class)
- Osmotic Activity - [MoA] (Mechanism of Action)
- Osmotic Laxative - [EPC] (Established Pharmacologic Class)
- Vitamin C - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 64661 - Jaymac Pharmaceuticals
- 64661-217 - Paxlyte
- 64661-217-30 - 30 CAPSULE in 1 BOTTLE
- 64661-217 - Paxlyte
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.
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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 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 phosphate anhydrous; flavin adenine dinucleotide; nadh; cobamamide; cocarboxylase; magnesium ascorbate; zinc ascorbate; magnesium l-threonate; betaine; citric acid monohydrate; sodium citrate 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.