Vaccine · BLA
Havrix (hepatitis a vaccine) NDC 50090-3781
Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated) 720 [iU]/.5mL · Injection, Suspension · Intramuscular · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-3781-0 | 50090378100 | 10 SYRINGE in 1 CARTON (50090-3781-0) / .5 mL in 1 SYRINGE (50090-3781-1)Marketed from Feb 16, 2007 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Havrix
- Generic name (nonproprietary)
- hepatitis a vaccine
- Active ingredients
- Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated) — 720 [iU]/.5mL
- Dosage form
- Injection, Suspension
- Route
- Intramuscular
- Labeler
- A-S Medication Solutions
- Product type
- Vaccine
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103475
- Marketing start
- Listing expires
- Other FDA classes
- Actively Acquired Immunity (Physiologic effect)Hepatitis A Vaccines (Chemical structure)Inactivated (Chemical structure)
- Identifiers
- Product ID 50090-3781_e0a78abf-4f24-4c13-ac00-6c193441275dSPL ID e0a78abf-4f24-4c13-ac00-6c193441275d
- Pharmacologic class
- Inactivated Hepatitis A 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
N450090378100followed by a unit qualifier and the quantityPackage 50090-3781-00. 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 103475
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 |
|---|---|---|---|---|
| Havrixhepatitis a vaccine | Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated) 1440 [iU]/mL | Injection, SuspensionIntramuscular | GlaxoSmithKline Biologicals SA | 58160-826 |
| Havrixhepatitis a vaccine | Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated) 720 [iU]/.5mL | Injection, SuspensionIntramuscular | GlaxoSmithKline Biologicals SA | 58160-825 |
| Havrixhepatitis a vaccine | Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated) 1440 [iU]/mL | Injection, SuspensionIntramuscular | A-S Medication Solutions | 50090-1502 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.