Vaccine · BLA
Engerix-B (Hepatitis b vaccine (recombinant)) NDC 58160-821
Hepatitis b virus subtype adw2 hbsag surface protein antigen 20 ug/mL · Injection, Suspension · Intramuscular · GlaxoSmithKline Biologicals SA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58160-821-11 | 5816008211158160082111 | 10 VIAL in 1 CARTON (58160-821-11) / 1 mL in 1 VIAL (58160-821-01)Marketed from Mar 28, 2007 | |
| 58160-821-52 | 5816008215258160082152 | 10 SYRINGE in 1 CARTON (58160-821-52) / 1 mL in 1 SYRINGE (58160-821-43)Marketed from Mar 28, 2007 |
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)
- Engerix-B
- Generic name (nonproprietary)
- hepatitis b vaccine (recombinant)
- Active ingredients
- Hepatitis b virus subtype adw2 hbsag surface protein antigen — 20 ug/mL
- Dosage form
- Injection, Suspension
- Route
- Intramuscular
- Labeler
- GlaxoSmithKline Biologicals SANDC labeler code 58160
- Product type
- Vaccine
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103239
- Marketing start
- Listing expires
- Identifiers
- Product ID 58160-821_b3c5a55f-bf21-4cea-9fce-715face6eeb0SPL ID b3c5a55f-bf21-4cea-9fce-715face6eeb0
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
N458160082111followed by a unit qualifier and the quantityPackage 58160-0821-11. 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 58160-821
- What is NDC 58160-821?
- 58160-821 is the product NDC for Engerix-B (hepatitis b vaccine (recombinant)), Hepatitis b virus subtype adw2 hbsag surface protein antigen 20 ug/mL injection, suspension, listed with the FDA by GlaxoSmithKline Biologicals SA. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Engerix-B (Hepatitis B Vaccine (Recombinant)).
- What is the active ingredient?
- Hepatitis b virus subtype adw2 hbsag surface protein antigen.
- Who is the labeler?
- GlaxoSmithKline Biologicals SA, NDC labeler code 58160. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Engerix-B?
- 2 other product NDCs are listed under this name. See all Engerix-B NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Engerix-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) |
|---|---|---|---|---|---|
| Engerix-Bhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw2 hbsag surface protein antigen 10 ug/.5mL | Injection, SuspensionIntramuscular | GlaxoSmithKline Biologicals SA | 58160-820 | 58160-0820-52 |
| Engerix-Bhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw2 hbsag surface protein antigen 20 ug/mL | Injection, SuspensionIntramuscular | A-S Medication Solutions | 50090-1223 | 50090-1223-0150090-1223-02 |
Other NDCs under BLA 103239
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 |
|---|---|---|---|---|
| Engerix-Bhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw2 hbsag surface protein antigen 20 ug/mL | Injection, SuspensionIntramuscular | A-S Medication Solutions | 50090-1223 |
| Engerix-Bhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw2 hbsag surface protein antigen 10 ug/.5mL | Injection, SuspensionIntramuscular | GlaxoSmithKline Biologicals SA | 58160-820 |