NDC codes

FDA NDC Directory
Product NDC (as listed)58160-824Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58160-0824Add 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
58160-824-1558160082415581600824151 KIT in 1 CARTON (58160-824-15) * .5 mL in 1 VIAL (58160-831-03) * .5 mL in 1 SYRINGE (58160-833-02)Marketed from Jun 3, 2022

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)
Priorix
Generic name (nonproprietary)
measels, mumps, and rubella vaccine, live
Dosage form
Kit
Labeler
GlaxoSmithKline Biologicals SANDC labeler code 58160
Product type
Vaccine
Marketing category
BLA — Biologics License ApplicationApplication BLA 125748
Marketing start
Listing expires
Identifiers
Product ID 58160-824_08472684-c352-4715-b5ba-9b46d4275484SPL ID 08472684-c352-4715-b5ba-9b46d4275484

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

N458160082415 followed by a unit qualifier and the quantity

Package 58160-0824-15. 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 58160-824

What is NDC 58160-824?
58160-824 is the product NDC for Priorix 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?
Priorix (Measels, Mumps, and Rubella Vaccine, Live).
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 Priorix?
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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