Havrix (Hepatitis a vaccine) NDC 58160-825

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

GlaxoSmithKline Biologicals SANDC labeler code 58160

Product type

Vaccine

Marketing category

BLA — Biologics License ApplicationApplication BLA 103475

Marketing start

Feb 16, 2007

Listing expires

Dec 31, 2027

Other FDA classes

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

Identifiers

Product ID 58160-825_da1bf14f-4608-4053-ba84-1875481ba838SPL ID da1bf14f-4608-4053-ba84-1875481ba838

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.

How CPT relates to drug billing

NDC on a medical claim

N458160082552 followed by a unit qualifier and the quantity Copy

Package 58160-0825-52. 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 58160-825

What is NDC 58160-825?

58160-825 is the product NDC for Havrix (hepatitis a vaccine), Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated) 720 [iU]/.5mL injection, suspension, listed with the FDA by GlaxoSmithKline Biologicals SA. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Havrix (Hepatitis A Vaccine).

What is the active ingredient?

Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated).

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 Havrix?

3 other product NDCs are listed under this name. See all Havrix NDCs.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory. See Billing references above.

Related NDCs: other Havrix products

Other finished products listed under the same name: strengths, forms and labelers.

Other NDCs under BLA 103475

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