What is NDC 80777-345?

80777-345 is the product NDC for mRESVIA (respiratory syncytial virus vaccine), RNA-100-ar02 50 ug/.5mL suspension, listed with the FDA by Moderna US, INC.. It has 6 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

mRESVIA (Respiratory Syncytial Virus Vaccine).

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 mRESVIA?

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.

mRESVIA NDC 80777-345 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80777-345Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80777-0345Add 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 NDC	11-digit (billing)	Package
80777-345-61	80777034561	10 SYRINGE in 1 CARTON (80777-345-61) / .5 mL in 1 SYRINGE (80777-345-01)Marketed from May 31, 2024
80777-345-62	80777034562	1 SYRINGE in 1 CARTON (80777-345-62) / .5 mL in 1 SYRINGE (80777-345-01)Marketed from May 31, 2024
80777-345-63	80777034563	2 SYRINGE in 1 CARTON (80777-345-63) / .5 mL in 1 SYRINGE (80777-345-01)Marketed from May 31, 2024
80777-345-89	80777034589	2 SYRINGE in 1 CARTON (80777-345-89) / .5 mL in 1 SYRINGE (80777-345-01)Marketed from May 31, 2024
80777-345-90	80777034590	1 SYRINGE in 1 CARTON (80777-345-90) / .5 mL in 1 SYRINGE (80777-345-01)Marketed from May 31, 2024
80777-345-96	80777034596	10 SYRINGE in 1 CARTON (80777-345-96) / .5 mL in 1 SYRINGE (80777-345-01)Marketed from May 31, 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): mRESVIA
Generic name (nonproprietary): respiratory syncytial virus vaccine
Active ingredients: RNA-100-ar02 — 50 ug/.5mL
Dosage form: Suspension
Route: Intramuscular
Labeler: Moderna US, INC.NDC labeler code 80777
Product type: Vaccine
Marketing category: BLA — Biologics License ApplicationApplication BLA 125796
Marketing start: May 31, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 80777-345_42531fa9-5b49-4ebe-8117-ce2fd97c0c53SPL ID 42531fa9-5b49-4ebe-8117-ce2fd97c0c53

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

N480777034561 followed by a unit qualifier and the quantity

Package 80777-0345-61. 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 80777-345

What is NDC 80777-345?: 80777-345 is the product NDC for mRESVIA (respiratory syncytial virus vaccine), RNA-100-ar02 50 ug/.5mL suspension, listed with the FDA by Moderna US, INC.. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: mRESVIA (Respiratory Syncytial Virus Vaccine).
What is the active ingredient?: RNA-100-ar02.
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 mRESVIA?: 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.

mRESVIA (Respiratory syncytial virus vaccine) NDC 80777-345