Vaccine · BLA
Recombivax Hb (Hepatitis b vaccine (recombinant)) NDC 0006-4093
Hepatitis b virus subtype adw hbsag surface protein antigen 5 ug/.5mL · Injection, Suspension · Intramuscular, Subcutaneous · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-4093-02 | 0000640930200006409302 | 10 SYRINGE in 1 CARTON (0006-4093-02) / .5 mL in 1 SYRINGE (0006-4093-01)Marketed from Jul 23, 1986 |
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)
- Recombivax Hb
- Generic name (nonproprietary)
- hepatitis b vaccine (recombinant)
- Active ingredients
- Hepatitis b virus subtype adw hbsag surface protein antigen — 5 ug/.5mL
- Dosage form
- Injection, Suspension
- Route
- Intramuscular, Subcutaneous
- Labeler
- Merck Sharp & Dohme LLCNDC labeler code 0006
- Product type
- Vaccine
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 101066
- Marketing start
- Listing expires
- Other FDA classes
- Actively Acquired Immunity (Physiologic effect)Hepatitis B Vaccines (Chemical structure)Inactivated (Chemical structure)
- Identifiers
- Product ID 0006-4093_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.
- NDC on a medical claim
N400006409302followed by a unit qualifier and the quantityPackage 00006-4093-02. 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 0006-4093
- What is NDC 0006-4093?
- 0006-4093 is the product NDC for Recombivax Hb (hepatitis b vaccine (recombinant)), Hepatitis b virus subtype adw hbsag surface protein antigen 5 ug/.5mL injection, suspension, listed with the FDA by Merck Sharp & Dohme LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Recombivax Hb (Hepatitis B Vaccine (Recombinant)).
- What is the active ingredient?
- Hepatitis b virus subtype adw hbsag surface protein antigen.
- Who is the labeler?
- Merck Sharp & Dohme LLC, NDC labeler code 0006. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Recombivax Hb?
- 6 other product NDCs are listed under this name. See all Recombivax Hb NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Recombivax Hb products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Recombivax Hbhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw hbsag surface protein antigen 5 ug/.5mL | Injection, SuspensionIntramuscular, Subcutaneous | Bamboo US BidCo LLC | 83703-085 | 83703-0085-02 |
| Recombivax Hbhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw hbsag surface protein antigen 10 ug/mL | Injection, SuspensionIntramuscular, Subcutaneous | Bamboo US BidCo LLC | 83703-086 | 83703-0086-02 |
| Recombivax Hbhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw hbsag surface protein antigen 10 ug/mL | Injection, SuspensionIntramuscular, Subcutaneous | Merck Sharp & Dohme LLC | 0006-4094 | 00006-4094-02 |
| Recombivax Hbhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw hbsag surface protein antigen 5 ug/.5mL | Injection, SuspensionIntramuscular, Subcutaneous | Merck Sharp & Dohme LLC | 0006-4981 | 00006-4981-00 |
| Recombivax Hbhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw hbsag surface protein antigen 40 ug/mL | Injection, SuspensionIntramuscular, Subcutaneous | Merck Sharp & Dohme LLC | 0006-4992 | 00006-4992-00 |
| Recombivax Hbhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw hbsag surface protein antigen 10 ug/mL | Injection, SuspensionIntramuscular, Subcutaneous | Merck Sharp & Dohme LLC | 0006-4995 | 00006-4995-0000006-4995-41 |
Other NDCs under BLA 101066
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Recombivax Hbhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw hbsag surface protein antigen 10 ug/mL | Injection, SuspensionIntramuscular, Subcutaneous | Merck Sharp & Dohme LLC | 0006-4094 |
| Recombivax Hbhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw hbsag surface protein antigen 5 ug/.5mL | Injection, SuspensionIntramuscular, Subcutaneous | Merck Sharp & Dohme LLC | 0006-4981 |
| Recombivax Hbhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw hbsag surface protein antigen 40 ug/mL | Injection, SuspensionIntramuscular, Subcutaneous | Merck Sharp & Dohme LLC | 0006-4992 |
| Recombivax Hbhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw hbsag surface protein antigen 10 ug/mL | Injection, SuspensionIntramuscular, Subcutaneous | Merck Sharp & Dohme LLC | 0006-4995 |
| Recombivax Hbhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw hbsag surface protein antigen 5 ug/.5mL | Injection, SuspensionIntramuscular, Subcutaneous | Bamboo US BidCo LLC | 83703-085 |
| Recombivax Hbhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw hbsag surface protein antigen 10 ug/mL | Injection, SuspensionIntramuscular, Subcutaneous | Bamboo US BidCo LLC | 83703-086 |