Vaxelis NDC 63361-243

NDC codes

FDA NDC Directory

Product NDC (as listed)63361-243Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63361-0243Add 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	Copy
63361-243-15	63361024315	10 SYRINGE in 1 PACKAGE (63361-243-15) / .5 mL in 1 SYRINGE (63361-243-88)Marketed from Dec 21, 2018

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): Vaxelis
Generic name (nonproprietary): diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine
Active ingredients: Corynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated) — 15 [Lf]/.5mLClostridium tetani toxoid antigen (Formaldehyde inactivated) — 5 [Lf]/.5mLBordetella pertussis toxoid antigen (Glutaraldehyde inactivated) — 20 ug/.5mLBordetella pertussis filamentous hemagglutinin antigen (Formaldehyde inactivated) — 20 ug/.5mLBordetella pertussis pertactin antigen — 3 ug/.5mLBordetella pertussis fimbriae 2/3 antigen — 5 ug/.5mLPoliovirus type 1 antigen (Formaldehyde inactivated) — 29 [D'ag'U]/.5mLPoliovirus type 2 antigen (Formaldehyde inactivated) — 7 [D'ag'U]/.5mLPoliovirus type 3 antigen (Formaldehyde inactivated) — 26 [D'ag'U]/.5mLHepatitis b virus subtype adw hbsag surface protein antigen — 10 ug/.5mLHaemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen — 3 ug/.5mL
Dosage form: Injection, Suspension
Route: Intramuscular
Labeler: MSP Vaccine Company
Product type: Vaccine
Marketing category: BLA — Biologics License ApplicationApplication BLA 125563
Marketing start: Dec 21, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Diphtheria Toxoid (Chemical structure)Haemophilus Vaccines (Chemical structure)Hepatitis B Vaccines (Chemical structure)Pertussis Vaccine (Chemical structure)Pertussis Vaccine (Chemical structure)Pertussis Vaccine (Chemical structure)Poliovirus Vaccines (Chemical structure)Poliovirus Vaccines (Chemical structure)Poliovirus Vaccines (Chemical structure)Tetanus Toxoid (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)
Identifiers: Product ID 63361-243_899b15fd-89c2-44ab-95c8-a457ea7cf0beSPL ID 899b15fd-89c2-44ab-95c8-a457ea7cf0be
Pharmacologic class: Inactivated Bordetella Pertussis Vaccine; Inactivated Clostridium Tetani Vaccine; Inactivated Corynebacterium Diphtheriae Vaccine; Inactivated Haemophilus Influenzae B Vaccine; Inactivated Hepatitis B Virus Vaccine; Inactivated Poliovirus Vaccine

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

N463361024315 followed by a unit qualifier and the quantity

Package 63361-0243-15. 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.