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 |
|---|---|
| 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 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 6WJM73T46K, 9ABD9DRK7B, 3SCV180C9W, 2968PHW8QP, F0R1QK73KB, Q57971654Y, 8B4OP7RK5N, ZC44YTI8KK, 935E97BOY8, Q573I9DVLP, 1VZZ62R081, 0N1G678593, 1Y26ZZ0OTM, 4J24DQ0916, 394XK0IH40, F06SGE49M6, 1Q73Q2JULR, 9TI35313XW |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64661-217-30 | PaxLyte | 30 in 1 BOTTLE | CAPSULE | 30 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64661-217-30 | EA - Each | 64661-217 | d7cbd535-6ae0-420a-8944-75f409450c5f | 1 | 2025-05-14 |
DailyMed Dashboard NDC Coverage#
| 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 |
Packages#
| 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 | Historical |