What is NDC 84552-500?

84552-500 is the product NDC for Gozellix (gozetotide) kit, listed with the FDA by Telix Innovations SA. It has 2 package NDCs, shown above in 10- and 11-digit form.

Telix Innovations SA, NDC labeler code 84552. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Gozellix?

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.

Gozellix NDC 84552-500 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)84552-500Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84552-0500Add 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
84552-500-25	84552050025	1 KIT in 1 CARTON (84552-500-25) * 2.5 mL in 1 VIAL, MULTI-DOSE (84552-502-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (84552-503-64) * 2 mL in 1 AMPULE (84552-504-25) * 1 POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE (84552-501-25)Marketed from Mar 20, 2025
84552-500-64	84552050064	1 KIT in 1 CARTON (84552-500-64) * 2.5 mL in 1 VIAL, MULTI-DOSE (84552-502-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (84552-503-64) * 2 mL in 1 AMPULE (84552-504-25) * 1 POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE (84552-501-25)Marketed from Mar 20, 2025

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): Gozellix
Generic name (nonproprietary): gozetotide
Dosage form: Kit
Labeler: Telix Innovations SANDC labeler code 84552
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 219592
Marketing start: Mar 20, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 84552-500_334df051-2b2d-01fe-e063-6394a90a05f5SPL ID 334df051-2b2d-01fe-e063-6394a90a05f5SPL set ID abeab169-e38e-433a-b8a9-f1dab31518c8

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.

NDC on a medical claim

N484552050025 followed by a unit qualifier and the quantity

Package 84552-0500-25. 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

Current FDA label (SPL), effective Apr 11, 2025.

Indications (excerpt from the label)

GOZELLIX, after radiolabeling with Ga 68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for initial definitive therapy. With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. GOZELLIX, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for initial definitive therapy. With suspected recurrence based on elevated serum prosta…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 84552-500

What is NDC 84552-500?: 84552-500 is the product NDC for Gozellix (gozetotide) kit, listed with the FDA by Telix Innovations SA. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Gozellix (Gozetotide).
Who is the labeler?: Telix Innovations SA, NDC labeler code 84552. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gozellix?: 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.

Gozellix (Gozetotide) NDC 84552-500