Home NDC 64661-217 PaxLyte
Product NDC 64661-217
11-digit product format 646610217
Labeler code 64661
Product ID 64661-217_27a4406e-5cdf-46d7-bb01-38806ae851cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary 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
Dosage form CAPSULE
Route ORAL
Labeler Jaymac Pharmaceuticals
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-08-01
Substance 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
Active strength 6.4; 800; 500; 1.83; 50; 25; 13.6; 25; 1; 2.5; 7; 24; 1; 25; 12; 25; 1.83; 1 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
Pharmacologic 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base PaxLyte
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEUCOVORIN 2.5 mg/1 FOLIC ACID 1 mg/1 LEVOMEFOLATE MAGNESIUM 7 mg/1 FERROUS CYSTEINE GLYCINATE 13.6 mg/1 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 6.4 mg/1 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM 800 ug/1 PHOSPHATIDYL SERINE 12 mg/1 PYRIDOXAL PHOSPHATE ANHYDROUS 25 ug/1 FLAVIN ADENINE DINUCLEOTIDE 25 ug/1 NADH 25 ug/1 COBAMAMIDE 50 ug/1 COCARBOXYLASE 25 ug/1 MAGNESIUM ASCORBATE 24 mg/1 ZINC ASCORBATE 1 mg/1 MAGNESIUM L-THREONATE 1 mg/1 BETAINE 500 mg/1 CITRIC ACID MONOHYDRATE 1.83 mg/1 SODIUM CITRATE 1.83 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 18 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64661-217-30 PaxLyte 30 in 1 BOTTLE CAPSULE 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64661-217 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) CAPSULE [JAYMAC PHARMACEUTICALS] 4 Current NDC, 1 package rows 20241222_f520b130-61b3-443e-aaf6-91e094e7a334.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Jaymac Pharmaceuticals f520b130-61b3-443e-aaf6-91e094e7a334 2025-12-08 Warnings, Adverse reactions Exact identifier ndc (product): 64661-217
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64661-217-30 64661021730 30 CAPSULE in 1 BOTTLE (64661-217-30) 30 capsule 2024-08-01 No No Current