NDC codes

FDA NDC Directory
Product NDC (as listed)73475-3102Labeler and product segments. Claims need a package NDC.
Product NDC at billing width73475-3102Add 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
73475-3102-3734753102031 VIAL, SINGLE-DOSE in 1 CARTON (73475-3102-3) / 5.6 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 20, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
VYVGART Hytrulo
Generic name (nonproprietary)
efgartigimod alfa and hyaluronidase (human recombinant)
Active ingredients
Efgartigimod alfa — 180 mg/mLHyaluronidase (Human recombinant) — 2000 U/mL
Dosage form
Injection, Solution
Route
Subcutaneous
Labeler
argenx USNDC labeler code 73475
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 761304
Marketing start
Listing expires
Other FDA classes
Glycoside Hydrolases (Chemical structure)Neonatal Fc Receptor Blockers (Mechanism)
Identifiers
Product ID 73475-3102_a2607d4b-76e8-4004-94c2-190fdc8593fbSPL ID a2607d4b-76e8-4004-94c2-190fdc8593fbSPL set ID 7104d9e5-9910-47f5-9a93-741ac50f43b6RxCUI 2639951, 2639957, 2712083, 2712088UNII 743QUY4VD8, 961YV2O515
Pharmacologic class
Endoglycosidase; Neonatal Fc Receptor Blocker

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N473475310203 followed by a unit qualifier and the quantity

Package 73475-3102-03. 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)

VYVGART HYTRULO is indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) chronic inflammatory demyelinating polyneuropathy (CIDP) VYVGART HYTRULO is a combination of efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) ( 1 ) chronic inflammatory demyelinating polyneuropathy (CIDP) ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 73475-3102

What is NDC 73475-3102?
73475-3102 is the product NDC for VYVGART Hytrulo, Efgartigimod alfa 180 mg/mL; Hyaluronidase (Human recombinant) 2000 U/mL injection, solution, listed with the FDA by argenx US. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
VYVGART Hytrulo (Efgartigimod alfa and hyaluronidase (human recombinant)).
What is the active ingredient?
Efgartigimod alfa, Hyaluronidase (Human recombinant).
Who is the labeler?
argenx US, NDC labeler code 73475. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for VYVGART Hytrulo?
1 other product NDC are listed under this name. See all VYVGART Hytrulo NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other VYVGART Hytrulo NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
VYVGART Hytruloefgartigimod alfa and hyaluronidase (human recombinant)Efgartigimod alfa 200 mg/mL; Hyaluronidase (Human recombinant) 2000 U/mLInjection, SolutionSubcutaneousargenx US73475-122173475-1221-0173475-1221-04

Other NDCs under BLA 761304

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 761304
ProductStrengthForm · routeLabelerProduct NDC
VYVGART Hytruloefgartigimod alfa and hyaluronidase (human recombinant)Efgartigimod alfa 200 mg/mL; Hyaluronidase (Human recombinant) 2000 U/mLInjection, SolutionSubcutaneousargenx US73475-1221

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