paxlyte

Generic: 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

Labeler: jaymac pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name paxlyte
Generic 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
Labeler jaymac pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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, citric acid monohydrate 1.83 mg/1, cobamamide 50 ug/1, cocarboxylase 25 ug/1, ferrous cysteine glycinate 13.6 mg/1, flavin adenine dinucleotide 25 ug/1, folic acid 1 mg/1, leucovorin 2.5 mg/1, levomefolate magnesium 7 mg/1, magnesium ascorbate 24 mg/1, magnesium l-threonate 1 mg/1, nadh 25 ug/1, phosphatidyl serine 12 mg/1, pyridoxal phosphate anhydrous 25 ug/1, sodium citrate 1.83 mg/1, zinc ascorbate 1 mg/1

Manufacturer
Jaymac Pharmaceuticals

Identifiers & Regulatory

Product NDC 64661-217
Product ID 64661-217_27a4406e-5cdf-46d7-bb01-38806ae851cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2024-08-01

Pharmacologic Class

Established (EPC)
methylating agent [epc] folate analog [epc]
Mechanism of Action
methylating activity [moa]
Chemical Structure
folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64661217
Hyphenated Format 64661-217

Supplemental Identifiers

UPC
0364661217307
UNII
6WJM73T46K 9ABD9DRK7B 3SCV180C9W 2968PHW8QP F0R1QK73KB Q57971654Y 8B4OP7RK5N ZC44YTI8KK 935E97BOY8 Q573I9DVLP 1VZZ62R081 0N1G678593 1Y26ZZ0OTM 4J24DQ0916 394XK0IH40 F06SGE49M6 1Q73Q2JULR 9TI35313XW
NUI
N0000175804 N0000175805 N0000178369 M0008658

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name paxlyte (source: ndc)
Generic 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 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.4 mg/1
  • 800 ug/1
  • 500 mg/1
  • 1.83 mg/1
  • 50 ug/1
  • 25 ug/1
  • 13.6 mg/1
  • 1 mg/1
  • 2.5 mg/1
  • 7 mg/1
  • 24 mg/1
  • 12 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (64661-217-30)
source: ndc

Packages (1)

64661-217-30 30 CAPSULE in 1 BOTTLE (64661-217-30)

Ingredients (18)

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) citric acid monohydrate (1.83 mg/1) cobamamide (50 ug/1) cocarboxylase (25 ug/1) ferrous cysteine glycinate (13.6 mg/1) flavin adenine dinucleotide (25 ug/1) folic acid (1 mg/1) leucovorin (2.5 mg/1) levomefolate magnesium (7 mg/1) magnesium ascorbate (24 mg/1) magnesium l-threonate (1 mg/1) nadh (25 ug/1) phosphatidyl serine (12 mg/1) pyridoxal phosphate anhydrous (25 ug/1) sodium citrate (1.83 mg/1) zinc ascorbate (1 mg/1)

Linked Drug Pages (1)

PaxLyte ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "27a4406e-5cdf-46d7-bb01-38806ae851cb", "openfda": {"nui": ["N0000175804", "N0000175805", "N0000178369", "M0008658"], "upc": ["0364661217307"], "unii": ["6WJM73T46K", "9ABD9DRK7B", "3SCV180C9W", "2968PHW8QP", "F0R1QK73KB", "Q57971654Y", "8B4OP7RK5N", "ZC44YTI8KK", "935E97BOY8", "Q573I9DVLP", "1VZZ62R081", "0N1G678593", "1Y26ZZ0OTM", "4J24DQ0916", "394XK0IH40", "F06SGE49M6", "1Q73Q2JULR", "9TI35313XW"], "spl_set_id": ["f520b130-61b3-443e-aaf6-91e094e7a334"], "pharm_class_cs": ["Folic Acid [CS]"], "pharm_class_epc": ["Methylating Agent [EPC]", "Folate Analog [EPC]"], "pharm_class_moa": ["Methylating Activity [MoA]"], "manufacturer_name": ["Jaymac Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (64661-217-30)", "package_ndc": "64661-217-30", "marketing_start_date": "20240801"}], "brand_name": "PaxLyte", "product_id": "64661-217_27a4406e-5cdf-46d7-bb01-38806ae851cb", "dosage_form": "CAPSULE", "pharm_class": ["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]"], "product_ndc": "64661-217", "generic_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", "labeler_name": "Jaymac Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PaxLyte", "active_ingredients": [{"name": "1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM", "strength": "6.4 mg/1"}, {"name": "1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM", "strength": "800 ug/1"}, {"name": "BETAINE", "strength": "500 mg/1"}, {"name": "CITRIC ACID MONOHYDRATE", "strength": "1.83 mg/1"}, {"name": "COBAMAMIDE", "strength": "50 ug/1"}, {"name": "COCARBOXYLASE", "strength": "25 ug/1"}, {"name": "FERROUS CYSTEINE GLYCINATE", "strength": "13.6 mg/1"}, {"name": "FLAVIN ADENINE DINUCLEOTIDE", "strength": "25 ug/1"}, {"name": "FOLIC ACID", "strength": "1 mg/1"}, {"name": "LEUCOVORIN", "strength": "2.5 mg/1"}, {"name": "LEVOMEFOLATE MAGNESIUM", "strength": "7 mg/1"}, {"name": "MAGNESIUM ASCORBATE", "strength": "24 mg/1"}, {"name": "MAGNESIUM L-THREONATE", "strength": "1 mg/1"}, {"name": "NADH", "strength": "25 ug/1"}, {"name": "PHOSPHATIDYL SERINE", "strength": "12 mg/1"}, {"name": "PYRIDOXAL PHOSPHATE ANHYDROUS", "strength": "25 ug/1"}, {"name": "SODIUM CITRATE", "strength": "1.83 mg/1"}, {"name": "ZINC ASCORBATE", "strength": "1 mg/1"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20240801", "listing_expiration_date": "20261231"}