Prescription drug · UNAPPROVED DRUG OTHER
PaxLyte NDC 64661-217
Leucovorin 2.5 mg/1 + 17 more ingredients · Capsule · Oral · Jaymac Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64661-217-30 | 6466102173064661021730 | 30 CAPSULE in 1 BOTTLE (64661-217-30)Marketed from Aug 1, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- PaxLyte
- Generic name (nonproprietary)
- 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 ingredients
- Leucovorin — 2.5 mg/1Folic acid — 1 mg/1Levomefolate magnesium — 7 mg/1Ferrous cysteine glycinate — 13.6 mg/11,2-docosahexanoyl-sn-glycero-3-phosphoserine calcium — 6.4 mg/11,2-icosapentoyl-sn-glycero-3-phosphoserine calcium — 800 ug/1Phosphatidyl serine — 12 mg/1Pyridoxal phosphate anhydrous — 25 ug/1Flavin adenine dinucleotide — 25 ug/1Nadh — 25 ug/1Cobamamide — 50 ug/1Cocarboxylase — 25 ug/1Magnesium ascorbate — 24 mg/1Zinc ascorbate — 1 mg/1Magnesium l-threonate — 1 mg/1Betaine — 500 mg/1Citric acid monohydrate — 1.83 mg/1Sodium citrate — 1.83 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Jaymac PharmaceuticalsNDC labeler code 64661
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Ascorbic Acid (Chemical structure)Ascorbic Acid (Chemical structure)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)Folic Acid (Chemical structure)Folic Acid (Chemical structure)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Methylating Activity (Mechanism)Osmotic Activity (Mechanism)
- Identifiers
- Product ID 64661-217_27a4406e-5cdf-46d7-bb01-38806ae851cbSPL ID 27a4406e-5cdf-46d7-bb01-38806ae851cbSPL set ID f520b130-61b3-443e-aaf6-91e094e7a334UNII Q573I9DVLP, 935E97BOY8, 1VZZ62R081, 8B4OP7RK5N, 6WJM73T46K, 9ABD9DRK7B, 394XK0IH40, F06SGE49M6, ZC44YTI8KK, 4J24DQ0916, F0R1QK73KB, Q57971654Y, 0N1G678593, 9TI35313XW, 1Y26ZZ0OTM, 3SCV180C9W, 2968PHW8QP, 1Q73Q2JULRUPC 0364661217307
- Pharmacologic class
- Anti-coagulant; Calculi Dissolution Agent; Folate Analog; Methylating Agent; Osmotic Laxative; Vitamin C
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N464661021730followed by a unit qualifier and the quantityPackage 64661-0217-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATION PaxLyte is indicated in the TREATMENT of vitamin deficiency – specifically vitamin B 12 deficiency, and the PREVENTION of vitamin B 12 -cofactor deficiency, l-methylfolate.
Excerpt only. Read the full label for complete information.
About NDC 64661-217
- What is NDC 64661-217?
- 64661-217 is the product NDC for PaxLyte, Leucovorin 2.5 mg/1 + 17 more ingredients capsule, listed with the FDA by Jaymac Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this 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).
- What is the active ingredient?
- 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 phosphate anhydrous, Flavin adenine dinucleotide, Nadh, Cobamamide, Cocarboxylase, Magnesium ascorbate, Zinc ascorbate, Magnesium l-threonate, Betaine, Citric acid monohydrate, Sodium citrate.
- Who is the labeler?
- Jaymac Pharmaceuticals, NDC labeler code 64661. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for PaxLyte?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.