Recombivax Hb (hepatitis b vaccine (recombinant)) NDC 0006-4995

Product information

Brand name (proprietary)

Recombivax Hb

Generic name (nonproprietary)

hepatitis b vaccine (recombinant)

Active ingredients

Hepatitis b virus subtype adw hbsag surface protein antigen — 10 ug/mL

Dosage form

Injection, Suspension

Route

Intramuscular, Subcutaneous

Labeler

Merck Sharp & Dohme LLC

Product type

Vaccine

Marketing category

BLA — Biologics License ApplicationApplication BLA 101066

Marketing start

Jul 23, 1986

Listing expires

Dec 31, 2026

Other FDA classes

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

Identifiers

Product ID 0006-4995_32dbed7b-c62b-4294-8476-d134c8c1a6f4SPL ID 32dbed7b-c62b-4294-8476-d134c8c1a6f4

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

N400006499500 followed by a unit qualifier and the quantity Copy

Package 00006-4995-00. 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 101066

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