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NDC 64661-217 Paxlyte

Leucovorin,Folic Acid,Levomefolate Magnesium,Ferrous Cysteine Glycinate,1, - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 64661-217?
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Get all the details for National Drug Code (NDC) 64661-217 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
64661-217
Proprietary Name:
Paxlyte
Non-Proprietary Name: [1]
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: [2]
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
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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(s): [4]
Oral - Administration to or by way of the mouth.
Labeler Name: [5]
Jaymac Pharmaceuticals
Labeler Code:
64661
Product Label ID:
f520b130-61b3-443e-aaf6-91e094e7a334
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date: [9]
08-01-2024
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
BROWN (C48332 - (ANNATTO))
Shape:
OVAL (C48345)
Size(s):
14 MM
Imprint(s):
7N3
Score:
1

Code Structure Chart

Product Details

What is NDC 64661-217?

The NDC code 64661-217 is assigned by the FDA to the product Paxlyte which is a human prescription drug product labeled by Jaymac Pharmaceuticals. The generic name of Paxlyte is 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 product's dosage form is capsule and is administered via oral form. The product is distributed in a single package with assigned NDC code 64661-217-30 30 capsule in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are Paxlyte Active Ingredients?

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.
  • 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 6.4 mg/1
  • 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 800 ug/1
  • BETAINE 500 mg/1 - A naturally occurring compound that has been of interest for its role in osmoregulation. As a drug, betaine hydrochloride has been used as a source of hydrochloric acid in the treatment of hypochlorhydria. Betaine has also been used in the treatment of liver disorders, for hyperkalemia, for homocystinuria, and for gastrointestinal disturbances. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1341)
  • CITRIC ACID MONOHYDRATE 1.83 mg/1 - A key intermediate in metabolism. It is an acid compound found in citrus fruits. The salts of citric acid (citrates) can be used as anticoagulants due to their calcium chelating ability.
  • COBAMAMIDE 50 ug/1
  • COCARBOXYLASE 25 ug/1
  • FERROUS CYSTEINE GLYCINATE 13.6 mg/1
  • FLAVIN ADENINE DINUCLEOTIDE 25 ug/1 - A condensation product of riboflavin and adenosine diphosphate. The coenzyme of various aerobic dehydrogenases, e.g., D-amino acid oxidase and L-amino acid oxidase. (Lehninger, Principles of Biochemistry, 1982, p972)
  • FOLIC ACID 1 mg/1 - A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (POACEAE). Folic acid is used in the treatment and prevention of folate deficiencies and megaloblastic anemia.
  • LEUCOVORIN 2.5 mg/1 - The active metabolite of FOLIC ACID. Leucovorin is used principally as an antidote to FOLIC ACID ANTAGONISTS.
  • LEVOMEFOLATE MAGNESIUM 7 mg/1
  • MAGNESIUM ASCORBATE 24 mg/1 - A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.
  • MAGNESIUM L-THREONATE 1 mg/1
  • NADH 25 ug/1 - A coenzyme composed of ribosylnicotinamide 5'-diphosphate coupled to adenosine 5'-phosphate by pyrophosphate linkage. It is found widely in nature and is involved in numerous enzymatic reactions in which it serves as an electron carrier by being alternately oxidized (NAD+) and reduced (NADH). (Dorland, 27th ed)
  • PHOSPHATIDYL SERINE 12 mg/1 - Derivatives of PHOSPHATIDIC ACIDS in which the phosphoric acid is bound in ester linkage to a SERINE moiety.
  • PYRIDOXAL PHOSPHATE ANHYDROUS 25 ug/1
  • SODIUM CITRATE 1.83 mg/1 - Sodium salts of citric acid that are used as buffers and food preservatives. They are used medically as anticoagulants in stored blood, and for urine alkalization in the prevention of KIDNEY STONES.
  • ZINC ASCORBATE 1 mg/1

Which are Paxlyte UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Paxlyte Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

Which are the Pharmacologic Classes for Paxlyte?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - 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.

[3] What kind of product is this? - 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.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[8] What is the Marketing Category? - 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".