NDC codes

FDA NDC Directory
Product NDC (as listed)64661-217Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64661-0217Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
64661-217-30646610217306466102173030 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
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

N464661021730 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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