What is NDC 58160-725?

58160-725 is the product NDC for Fluarix 2026/2027 (influenza virus vaccine), Influenza a virus a/victoria/4897/2022 ivr-238 (H1n1) antigen (Formaldehyde inactivated) 15 ug/.5mL + 2 more ingredients 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?

Fluarix 2026/2027 (Influenza virus vaccine).

What is the active ingredient?

Influenza a virus a/victoria/4897/2022 ivr-238 (H1n1) antigen (Formaldehyde inactivated), Influenza a virus a/croatia/10136rv/2023 x-425a (H3n2) antigen (Formaldehyde inactivated), Influenza b virus b/austria/1359417/2021 bvr-26 antigen (Formaldehyde inactivated).

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 Fluarix 2026/2027?

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.

Fluarix 2026/2027 NDC 58160-725 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58160-725Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58160-0725Add 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
58160-725-52	5816007255258160072552	10 SYRINGE in 1 CARTON (58160-725-52) / .5 mL in 1 SYRINGE (58160-725-41)Marketed from Jul 1, 2026

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): Fluarix 2026/2027Suffix: 2026/2027
Generic name (nonproprietary): influenza virus vaccine
Active ingredients: Influenza a virus a/victoria/4897/2022 ivr-238 (H1n1) antigen (Formaldehyde inactivated) — 15 ug/.5mLInfluenza a virus a/croatia/10136rv/2023 x-425a (H3n2) antigen (Formaldehyde inactivated) — 15 ug/.5mLInfluenza b virus b/austria/1359417/2021 bvr-26 antigen (Formaldehyde inactivated) — 15 ug/.5mL
Dosage form: Suspension
Route: Intramuscular
Labeler: GlaxoSmithKline Biologicals SANDC labeler code 58160
Product type: Vaccine
Marketing category: BLA — Biologics License ApplicationApplication BLA 125127
Marketing start: Jul 1, 2026
Marketing end: Jun 30, 2027
Identifiers: Product ID 58160-725_2d728e3c-d550-47fb-8fa9-3ce0f244512bSPL ID 2d728e3c-d550-47fb-8fa9-3ce0f244512b

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

N458160072552 followed by a unit qualifier and the quantity

Package 58160-0725-52. 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 58160-725

What is NDC 58160-725?: 58160-725 is the product NDC for Fluarix 2026/2027 (influenza virus vaccine), Influenza a virus a/victoria/4897/2022 ivr-238 (H1n1) antigen (Formaldehyde inactivated) 15 ug/.5mL + 2 more ingredients 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?: Fluarix 2026/2027 (Influenza virus vaccine).
What is the active ingredient?: Influenza a virus a/victoria/4897/2022 ivr-238 (H1n1) antigen (Formaldehyde inactivated), Influenza a virus a/croatia/10136rv/2023 x-425a (H3n2) antigen (Formaldehyde inactivated), Influenza b virus b/austria/1359417/2021 bvr-26 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 Fluarix 2026/2027?: 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.

Fluarix 2026/2027 (Influenza virus vaccine) NDC 58160-725