Vaccine · BLA
Abrysvo (Respiratory syncytial virus vaccine) NDC 0069-2465
Recombinant stabilized rsv a prefusion f antigen .06 mg/.5mL; Recombinant stabilized rsv b prefusion f antigen .06 mg/.5mL · Injection, Powder, Lyophilized, For solution · Intramuscular · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-2465-01 | 0006924650100069246501 | 1 VIAL in 1 CARTON (0069-2465-01) / .5 mL in 1 VIAL (0069-2465-19)Marketed from Jul 30, 2024 | |
| 0069-2465-10 | 0006924651000069246510 | 10 VIAL in 1 CARTON (0069-2465-10) / .5 mL in 1 VIAL (0069-2465-19)Marketed from Jul 30, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Abrysvo
- Generic name (nonproprietary)
- respiratory syncytial virus vaccine
- Active ingredients
- Recombinant stabilized rsv a prefusion f antigen — .06 mg/.5mLRecombinant stabilized rsv b prefusion f antigen — .06 mg/.5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- Product type
- Vaccine
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125769
- Marketing start
- Listing expires
- Identifiers
- Product ID 0069-2465_c3db32ba-8a3e-47d3-9dde-26a65f7bd0c0SPL ID c3db32ba-8a3e-47d3-9dde-26a65f7bd0c0
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 codeMed-Code curated
CPT 90678 — Vaccine product code for ABRYSVO (respiratory syncytial virus vaccine, bivalent)
Billing unit: 1 dose. Units on the claim = dose given ÷ 1 dose.
- 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
N400069246501followed by a unit qualifier and the quantityPackage 00069-2465-01. 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 0069-2465
- What is NDC 0069-2465?
- 0069-2465 is the product NDC for Abrysvo (respiratory syncytial virus vaccine), Recombinant stabilized rsv a prefusion f antigen .06 mg/.5mL; Recombinant stabilized rsv b prefusion f antigen .06 mg/.5mL injection, powder, lyophilized, for solution, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Abrysvo (Respiratory Syncytial Virus Vaccine).
- What is the active ingredient?
- Recombinant stabilized rsv a prefusion f antigen, Recombinant stabilized rsv b prefusion f antigen.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Abrysvo?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Yes: 90678, Vaccine product code for ABRYSVO (respiratory syncytial virus vaccine, bivalent). See Billing references above.