Vaccine · BLA
mNEXSPIKE (Covid-19 vaccine, mrna) NDC 80777-401
Cx-055610 10 ug/.2mL · Injection, Suspension · Intramuscular · Moderna US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80777-401-60 | 80777040160 | 10 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.
- NDC on a medical claim
N480777040160followed by a unit qualifier and the quantityPackage 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.