Vaccine · BLA
Heplisav-B NDC 83703-048
hepatitis b vaccine (recombinant) adjuvanted · Hepatitis b virus subtype adw hbsag surface protein antigen 20 ug/.5mL · Injection, Solution · Intramuscular · Bamboo US BidCo LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83703-048-05 | 8370300480583703004805 | 5 SYRINGE in 1 CARTON (83703-048-05) / .5 mL in 1 SYRINGE (83703-048-01)Marketed from Jan 1, 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)
- 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 LLCNDC labeler code 83703
- Product type
- Vaccine
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125428
- Marketing start
- Listing expires
- 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.
- NDC on a medical claim
N483703004805followed by a unit qualifier and the quantityPackage 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.
About NDC 83703-048
- What is NDC 83703-048?
- 83703-048 is the product NDC for Heplisav-B, Hepatitis b virus subtype adw hbsag surface protein antigen 20 ug/.5mL injection, solution, listed with the FDA by Bamboo US BidCo LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Heplisav-B (Hepatitis B Vaccine (Recombinant) Adjuvanted).
- What is the active ingredient?
- Hepatitis b virus subtype adw hbsag surface protein antigen.
- Who is the labeler?
- Bamboo US BidCo LLC, NDC labeler code 83703. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Heplisav-B?
- 2 other product NDCs are listed under this name. See all Heplisav-B NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Heplisav-B products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Heplisav-Bhepatitis b vaccine (recombinant) adjuvanted | Hepatitis b virus subtype adw hbsag surface protein antigen 20 ug/.5mL | Injection, SolutionIntramuscular | Dynavax Technologies Corporation | 43528-003 | 43528-0003-05 |
| Heplisav-Bhepatitis b vaccine (recombinant) adjuvanted | Hepatitis b virus subtype adw hbsag surface protein antigen 20 ug/.5mL | Injection, SolutionIntramuscular | A-S Medication Solutions | 50090-4526 | 50090-4526-00 |
Other NDCs under BLA 125428
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 |
|---|---|---|---|---|
| Heplisav-Bhepatitis b vaccine (recombinant) adjuvanted | Hepatitis b virus subtype adw hbsag surface protein antigen 20 ug/.5mL | Injection, SolutionIntramuscular | Dynavax Technologies Corporation | 43528-003 |
| Heplisav-Bhepatitis b vaccine (recombinant) adjuvanted | Hepatitis b virus subtype adw hbsag surface protein antigen 20 ug/.5mL | Injection, SolutionIntramuscular | A-S Medication Solutions | 50090-4526 |