What is NDC 58160-815?

58160-815 is the product NDC for Twinrix, Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated) 720 [iU]/mL; Hepatitis b virus subtype adw2 hbsag surface protein antigen 20 ug/mL 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?

Twinrix (Hepatitis A and Hepatitis B (Recombinant) Vaccine).

What is the active ingredient?

Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated), Hepatitis b virus subtype adw2 hbsag surface protein antigen.

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 Twinrix?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Twinrix NDC 58160-815 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58160-815Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58160-0815Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
58160-815-52	5816008155258160081552	10 SYRINGE in 1 CARTON (58160-815-52) / 1 mL in 1 SYRINGE (58160-815-43)Marketed from Jun 7, 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): Twinrix
Generic name (nonproprietary): hepatitis a and hepatitis b (recombinant) vaccine
Active ingredients: Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated) — 720 [iU]/mLHepatitis 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 103850
Marketing start: Jun 7, 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 58160-815_f99d8a1b-e81c-4ccc-9a97-b47dc52039adSPL ID f99d8a1b-e81c-4ccc-9a97-b47dc52039ad
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

N458160081552 followed by a unit qualifier and the quantity

Package 58160-0815-52. 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 58160-815

What is NDC 58160-815?: 58160-815 is the product NDC for Twinrix, Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated) 720 [iU]/mL; Hepatitis b virus subtype adw2 hbsag surface protein antigen 20 ug/mL 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?: Twinrix (Hepatitis A and Hepatitis B (Recombinant) Vaccine).
What is the active ingredient?: Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated), 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 Twinrix?: 1 other product NDC are listed under this name. See all Twinrix NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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

Other Twinrix NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Twinrixhepatitis a and hepatitis b (recombinant) vaccine	Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated) 720 [iU]/mL; Hepatitis b virus subtype adw2 hbsag surface protein antigen 20 ug/mL	Injection, SuspensionIntramuscular	A-S Medication Solutions	50090-1645	50090-1645-00

Other NDCs under BLA 103850

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

FDA NDC Directory listings under BLA 103850
Product	Strength	Form · route	Labeler	Product NDC
Twinrixhepatitis a and hepatitis b (recombinant) vaccine	Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated) 720 [iU]/mL; Hepatitis b virus subtype adw2 hbsag surface protein antigen 20 ug/mL	Injection, SuspensionIntramuscular	A-S Medication Solutions	50090-1645