NDC codes

FDA NDC Directory
Product NDC (as listed)0069-2631Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00069-2631Add 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 NDC11-digit (billing)PackageCopy
0069-2631-100006926311010 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.

How CPT relates to drug billing

NDC on a medical claim

N400069263110 followed by a unit qualifier and the quantity

Package 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.

FDA NDC Directory listings under BLA 125742
ProductStrengthForm · routeLabelerProduct NDC
Comirnatycovid-19 vaccine, mrnaBnt162b2 omicron (LP.8.1) .042 mg/.418mLInjection, SuspensionIntramuscularPfizer Laboratories Div Pfizer Inc0069-2528
Comirnatycovid-19 vaccine, mrnaBnt162b2 omicron (LP.8.1) .0158 mg/.48mLInjection, SuspensionIntramuscularPfizer Laboratories Div Pfizer Inc0069-2501
Comirnatycovid-19 vaccine, mrnaBnt-162b2 omicron (Xfg) mrna .0158 mg/.48mLInjection, SuspensionIntramuscularPfizer Laboratories Div Pfizer Inc0069-2609

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Comirnaty NDC 0069-2631 | Med-Code