NDC codes

FDA NDC Directory
Product NDC (as listed)0069-2528Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00069-2528Add 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
0069-2528-100006925281010 SYRINGE, GLASS in 1 CARTON (0069-2528-10) / .418 mL in 1 SYRINGE, GLASS (0069-2528-01)Marketed from Aug 27, 2025

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
Bnt162b2 omicron (LP.8.1) — .042 mg/.418mL
Dosage form
Injection, Suspension
Route
Intramuscular
Labeler
Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
Product type
Vaccine
Marketing category
BLA — Biologics License ApplicationApplication BLA 125742
Marketing start
Marketing end
Identifiers
Product ID 0069-2528_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

N400069252810 followed by a unit qualifier and the quantity

Package 00069-2528-10. 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.

About NDC 0069-2528

What is NDC 0069-2528?
0069-2528 is the product NDC for Comirnaty, Bnt162b2 omicron (LP.8.1) .042 mg/.418mL injection, suspension, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Comirnaty (COVID-19 Vaccine, mRNA).
What is the active ingredient?
Bnt162b2 omicron (LP.8.1).
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 Comirnaty?
3 other product NDCs are listed under this name. See all Comirnaty NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Comirnaty NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Comirnatycovid-19 vaccine, mrnaBnt-162b2 omicron (Xfg) mrna .042 mg/.418mLInjection, SuspensionIntramuscularPfizer Laboratories Div Pfizer Inc0069-263100069-2631-10
Comirnatycovid-19 vaccine, mrnaBnt-162b2 omicron (Xfg) mrna .0158 mg/.48mLInjection, SuspensionIntramuscularPfizer Laboratories Div Pfizer Inc0069-260900069-2609-10
Comirnatycovid-19 vaccine, mrnaBnt162b2 omicron (LP.8.1) .0158 mg/.48mLInjection, SuspensionIntramuscularPfizer Laboratories Div Pfizer Inc0069-250100069-2501-10

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, mrnaBnt-162b2 omicron (Xfg) mrna .042 mg/.418mLInjection, SuspensionIntramuscularPfizer Laboratories Div Pfizer Inc0069-2631
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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