Heplisav-B NDC 83703-048

Product information

Brand name (proprietary)

Heplisav-B

Generic name (nonproprietary)

hepatitis b vaccine (recombinant) adjuvanted

Active ingredients

Hepatitis b virus subtype adw hbsag surface protein antigen — 20 ug/.5mL

Dosage form

Injection, Solution

Route

Intramuscular

Labeler

Bamboo US BidCo LLC

Product type

Vaccine

Marketing category

BLA — Biologics License ApplicationApplication BLA 125428

Marketing start

Jan 1, 2018

Listing expires

Dec 31, 2027

Other FDA classes

Actively Acquired Immunity (Physiologic effect)Hepatitis B Vaccines (Chemical structure)Inactivated (Chemical structure)

Identifiers

Product ID 83703-048_53e7f6a9-93df-5233-e063-6394a90ae22dSPL ID 53e7f6a9-93df-5233-e063-6394a90ae22d

Pharmacologic class

Inactivated Hepatitis B Virus 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

N483703004805 followed by a unit qualifier and the quantity Copy

Package 83703-0048-05. 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 125428

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.