What is NDC 58160-976?

58160-976 is the product NDC for Bexsero, Neisseria meningitidis group b nhba fusion protein antigen 50 ug/.5mL + 3 more ingredients 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?

Bexsero (NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN, NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN and NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN).

What is the active ingredient?

Neisseria meningitidis group b nhba fusion protein antigen, Neisseria meningitidis group b fhbp fusion protein antigen, Neisseria meningitidis group b NADA protein antigen, Neisseria meningitidis group b strain nz98/254 outer membrane vesicle 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 Bexsero?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bexsero NDC 58160-976 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58160-976Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58160-0976Add 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
58160-976-20	58160097620	10 SYRINGE in 1 CARTON (58160-976-20) / .5 mL in 1 SYRINGE (58160-976-02)Marketed from Dec 1, 2016

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): Bexsero
Generic name (nonproprietary): neisseria meningitidis serogroup b nhba fusion protein antigen, neisseria meningitidis serogroup b fhbp fusion protein antigen and neisseria meningitidis serogroup b nada protein antigen
Active ingredients: Neisseria meningitidis group b nhba fusion protein antigen — 50 ug/.5mLNeisseria meningitidis group b fhbp fusion protein antigen — 50 ug/.5mLNeisseria meningitidis group b NADA protein antigen — 50 ug/.5mLNeisseria meningitidis group b strain nz98/254 outer membrane vesicle antigen — 25 ug/.5mL
Dosage form: Injection, Suspension
Route: Intramuscular
Labeler: GlaxoSmithKline Biologicals SANDC labeler code 58160
Product type: Vaccine
Marketing category: BLA — Biologics License ApplicationApplication BLA 125546
Marketing start: Dec 1, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 58160-976_db17d990-e6e2-450c-b9ed-923ec92df84dSPL ID db17d990-e6e2-450c-b9ed-923ec92df84d

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

N458160097620 followed by a unit qualifier and the quantity

Package 58160-0976-20. 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 58160-976

What is NDC 58160-976?: 58160-976 is the product NDC for Bexsero, Neisseria meningitidis group b nhba fusion protein antigen 50 ug/.5mL + 3 more ingredients 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?: Bexsero (NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN, NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN and NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN).
What is the active ingredient?: Neisseria meningitidis group b nhba fusion protein antigen, Neisseria meningitidis group b fhbp fusion protein antigen, Neisseria meningitidis group b NADA protein antigen, Neisseria meningitidis group b strain nz98/254 outer membrane vesicle 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 Bexsero?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.