NDC codes

FDA NDC Directory
Product NDC (as listed)80777-401Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80777-0401Add 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
80777-401-608077704016010 SYRINGE, PLASTIC in 1 CARTON (80777-401-60) / .2 mL in 1 SYRINGE, PLASTIC (80777-401-17)Marketed from Aug 17, 2026

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)
mNEXSPIKE
Generic name (nonproprietary)
covid-19 vaccine, mrna
Active ingredients
Cx-055610 — 10 ug/.2mL
Dosage form
Injection, Suspension
Route
Intramuscular
Labeler
Moderna US, Inc.NDC labeler code 80777
Product type
Vaccine
Marketing category
BLA — Biologics License ApplicationApplication BLA 125835
Marketing start
Listing expires
Identifiers
Product ID 80777-401_d32253ba-dd1e-46ea-bbef-3eb1e135d91eSPL ID d32253ba-dd1e-46ea-bbef-3eb1e135d91e

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

Immunization administration (CPT 90460–90474)

Giving a vaccine is reported separately from the vaccine product code, with an immunization administration code. Which code applies depends on the patient's age, the route and whether counselling was provided.

How CPT relates to drug billing

NDC on a medical claim

N480777040160 followed by a unit qualifier and the quantity

Package 80777-0401-60. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 80777-401

What is NDC 80777-401?
80777-401 is the product NDC for mNEXSPIKE, Cx-055610 10 ug/.2mL injection, suspension, listed with the FDA by Moderna US, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
mNEXSPIKE (COVID-19 Vaccine, mRNA).
What is the active ingredient?
Cx-055610.
Who is the labeler?
Moderna US, Inc., NDC labeler code 80777. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for mNEXSPIKE?
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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