Vaccine · BLA
Spikevax (Covid-19 vaccine, mrna) NDC 80777-115
Cx-055611 25 ug/.25mL · Injection, Suspension · Intramuscular · Moderna US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80777-115-80 | 80777011580 | 10 SYRINGE, PLASTIC in 1 CARTON (80777-115-80) / .25 mL in 1 SYRINGE, PLASTIC (80777-115-09)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)
- Spikevax
- Generic name (nonproprietary)
- covid-19 vaccine, mrna
- Active ingredients
- Cx-055611 — 25 ug/.25mL
- Dosage form
- Injection, Suspension
- Route
- Intramuscular
- Labeler
- Moderna US, Inc.NDC labeler code 80777
- Product type
- Vaccine
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125752
- Marketing start
- Listing expires
- Identifiers
- Product ID 80777-115_7966274d-0378-44c8-9075-1df2c27aae9aSPL ID 7966274d-0378-44c8-9075-1df2c27aae9a
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
N480777011580followed by a unit qualifier and the quantityPackage 80777-0115-80. 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 80777-115
- What is NDC 80777-115?
- 80777-115 is the product NDC for Spikevax, Cx-055611 25 ug/.25mL 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?
- Spikevax (COVID-19 Vaccine, mRNA).
- What is the active ingredient?
- Cx-055611.
- 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 Spikevax?
- 1 other product NDC are listed under this name. See all Spikevax NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Spikevax products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Spikevaxcovid-19 vaccine, mrna | Cx-055611 50 ug/.5mL | Injection, SuspensionIntramuscular | Moderna US, Inc. | 80777-114 | 80777-0114-96 |
Other NDCs under BLA 125752
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Spikevaxcovid-19 vaccine, mrna | Cx-055611 50 ug/.5mL | Injection, SuspensionIntramuscular | Moderna US, Inc. | 80777-114 |