NDC codes

FDA NDC Directory
Product NDC (as listed)58160-855Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58160-0855Add 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 NDC11-digit (billing)PackageCopy
58160-855-195816008551910 VIAL in 1 CARTON (58160-855-19) / 2.5 mL in 1 VIAL (58160-855-01)Marketed from Nov 10, 2020

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)
As03
Generic name (nonproprietary)
as03
Dosage form
Injection, Solution
Route
Intramuscular
Labeler
GlaxoSmithKline Biologicals SANDC labeler code 58160
Product type
Vaccine
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 58160-855_16e1450f-1b3b-4cc3-8b67-b0fb63dadfd2SPL ID 16e1450f-1b3b-4cc3-8b67-b0fb63dadfd2

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

N458160085519 followed by a unit qualifier and the quantity

Package 58160-0855-19. 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 58160-855

What is NDC 58160-855?
58160-855 is the product NDC for As03 injection, solution, 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?
As03.
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 As03?
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.

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