What is NDC 58160-726?

58160-726 is the product NDC for Hiberix kit, 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?

Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)).

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 Hiberix?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hiberix NDC 58160-726 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58160-726Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58160-0726Add 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
58160-726-15	5816007261558160072615	1 KIT in 1 CARTON (58160-726-15) * .5 mL in 1 VIAL (58160-816-03) * .85 mL in 1 SYRINGE (58160-817-02)Marketed from Dec 20, 2023

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): Hiberix
Generic name (nonproprietary): haemophilus b conjugate vaccine (tetanus toxoid conjugate)
Dosage form: Kit
Labeler: GlaxoSmithKline Biologicals SANDC labeler code 58160
Product type: Vaccine
Marketing category: BLA — Biologics License ApplicationApplication BLA 125347
Marketing start: Dec 20, 2023
Listing expires: Dec 31, 2027
Identifiers: Product ID 58160-726_9b08a2e7-7437-4c42-85a0-63bde50b4ea3SPL ID 9b08a2e7-7437-4c42-85a0-63bde50b4ea3

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

N458160072615 followed by a unit qualifier and the quantity

Package 58160-0726-15. 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 58160-726

What is NDC 58160-726?: 58160-726 is the product NDC for Hiberix kit, 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?: Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)).
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 Hiberix?: 1 other product NDC are listed under this name. See all Hiberix 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 Hiberix NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hiberixhaemophilus b conjugate vaccine (tetanus toxoid conjugate)	—	Kit	GlaxoSmithKline Biologicals SA	58160-818	58160-0818-11

Other NDCs under BLA 125347

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

FDA NDC Directory listings under BLA 125347
Product	Strength	Form · route	Labeler	Product NDC
Hiberixhaemophilus b conjugate vaccine (tetanus toxoid conjugate)	—	Kit	GlaxoSmithKline Biologicals SA	58160-818