NDC codes

FDA NDC Directory
Product NDC (as listed)74725-100Labeler and product segments. Claims need a package NDC.
Product NDC at billing width74725-0100Add 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
74725-100-25747250100251 KIT in 1 CARTON (74725-100-25) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (74725-101-25) * 2.5 mL in 1 VIAL, MULTI-DOSE (74725-102-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (74725-103-64)Marketed from Dec 17, 2021
74725-100-64747250100641 KIT in 1 CARTON (74725-100-64) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (74725-101-25) * 2.5 mL in 1 VIAL, MULTI-DOSE (74725-102-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (74725-103-64)Marketed from Dec 17, 2021

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)
Illuccix
Generic name (nonproprietary)
kit for the preparation of gallium ga 68 gozetotide injection
Dosage form
Kit
Route
Intravenous
Labeler
Telix Pharmaceuticals (US) Inc.NDC labeler code 74725
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 214032
Marketing start
Listing expires
Identifiers
Product ID 74725-100_56f3be9c-a86f-4ce5-9e52-e9e57fb95464SPL ID 56f3be9c-a86f-4ce5-9e52-e9e57fb95464SPL set ID d4643b31-9b4f-673f-e053-2a95a90a559d

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

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N474725010025 followed by a unit qualifier and the quantity

Package 74725-0100-25. 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 .

Indications (excerpt from the label)

ILLUCCIX, 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 For selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products ILLUCCIX, 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 c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 74725-100

What is NDC 74725-100?
74725-100 is the product NDC for Illuccix kit, listed with the FDA by Telix Pharmaceuticals (US) Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Illuccix (Kit for the preparation of gallium Ga 68 gozetotide injection).
Who is the labeler?
Telix Pharmaceuticals (US) Inc., NDC labeler code 74725. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Illuccix?
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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