64661-217 NDC - 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)

Drug Information

Product NDC: 64661-217
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
Active Ingredient(s): 6.4 mg/1 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM; 800 ug/1 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM; 500 mg/1 BETAINE; 1.83 mg/1 CITRIC ACID MONOHYDRATE; 50 ug/1 COBAMAMIDE; 25 ug/1 COCARBOXYLASE; 13.6 mg/1 FERROUS CYSTEINE GLYCINATE; 25 ug/1 FLAVIN ADENINE DINUCLEOTIDE; 1 mg/1 FOLIC ACID; 2.5 mg/1 LEUCOVORIN; 7 mg/1 LEVOMEFOLATE MAGNESIUM; 24 mg/1 MAGNESIUM ASCORBATE; 1 mg/1 MAGNESIUM L-THREONATE; 25 ug/1 NADH; 12 mg/1 PHOSPHATIDYL SERINE; 25 ug/1 PYRIDOXAL PHOSPHATE ANHYDROUS; 1.83 mg/1 SODIUM CITRATE; 1 mg/1 ZINC ASCORBATE
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Pharmacy Class(es): Acidifying Activity [MoA]; Anti-coagulant [EPC]; Ascorbic Acid [CS]; Ascorbic Acid [CS]; Calcium Chelating Activity [MoA]; Calculi Dissolution Agent [EPC]; Decreased Coagulation Factor Activity [PE]; Folate Analog [EPC]; Folate Analog [EPC]; Folic Acid [CS]; Folic Acid [CS]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Methylating Activity [MoA]; Methylating Agent [EPC]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Vitamin C [EPC]; Vitamin C [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	Jaymac Pharmaceuticals
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED DRUG OTHER
Start Marketing Date:	8/1/2024

Package Information

No.	Package Code	Package Description	Billing Unit
1	64661-217-30	30 CAPSULE in 1 BOTTLE (64661-217-30)	EA

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	64661-217	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	PaxLyte	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
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	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	CAPSULE	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	8/1/2024	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	UNAPPROVED DRUG OTHER	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAME	Jaymac Pharmaceuticals	Name of Company corresponding to the labeler code segment of the Product NDC.
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	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	6.4; 800; 500; 1.83; 50; 25; 13.6; 25; 1; 2.5; 7; 24; 1; 25; 12; 25; 1.83; 1
ACTIVE INGRED UNIT	mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1
PHARM CLASSES	Acidifying Activity [MoA], Anti-coagulant [EPC], Ascorbic Acid [CS], Ascorbic Acid [CS], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Folate Analog [EPC], Folate Analog [EPC], Folic Acid [CS], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Methylating Activity [MoA], Methylating Agent [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Vitamin C [EPC], Vitamin C [EPC]

Drug Information

Labeler Information

Package Information

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