Vaccine · BLA
Comirnaty NDC 0069-2631
covid-19 vaccine, mrna · Bnt-162b2 omicron (Xfg) mrna .042 mg/.418mL · Injection, Suspension · Intramuscular · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-2631-10 | 00069263110 | 10 SYRINGE, GLASS in 1 CARTON (0069-2631-10) / .418 mL in 1 SYRINGE, GLASS (0069-2631-01)Marketed from Aug 27, 2026 |
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)
- Comirnaty
- Generic name (nonproprietary)
- covid-19 vaccine, mrna
- Active ingredients
- Bnt-162b2 omicron (Xfg) mrna — .042 mg/.418mL
- Dosage form
- Injection, Suspension
- Route
- Intramuscular
- Product type
- Vaccine
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125742
- Marketing start
- Listing expires
- Identifiers
- Product ID 0069-2631_0248cf65-e619-47eb-b9e2-355f9e797563SPL ID 0248cf65-e619-47eb-b9e2-355f9e797563
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
N400069263110followed by a unit qualifier and the quantityPackage 00069-2631-10. 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.
Other NDCs under BLA 125742
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 |
|---|---|---|---|---|
| Comirnatycovid-19 vaccine, mrna | Bnt162b2 omicron (LP.8.1) .042 mg/.418mL | Injection, SuspensionIntramuscular | Pfizer Laboratories Div Pfizer Inc | 0069-2528 |
| Comirnatycovid-19 vaccine, mrna | Bnt162b2 omicron (LP.8.1) .0158 mg/.48mL | Injection, SuspensionIntramuscular | Pfizer Laboratories Div Pfizer Inc | 0069-2501 |
| Comirnatycovid-19 vaccine, mrna | Bnt-162b2 omicron (Xfg) mrna .0158 mg/.48mL | Injection, SuspensionIntramuscular | Pfizer Laboratories Div Pfizer Inc | 0069-2609 |