Prescription drug · NDA
Gallium Ga-68 PSMA-11 (Gallium ga-68 gozetotide) NDC 76394-2642
Gallium ga-68 gozetotide 5 mCi/mL · Injection, Solution · Intravenous · UCLA Biomedical Cyclotron
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76394-2642-3 | 76394264203 | 12 mL in 1 VIAL, MULTI-DOSE (76394-2642-3)Marketed from Dec 9, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Gallium Ga-68 PSMA-11
- Generic name (nonproprietary)
- gallium ga-68 gozetotide
- Active ingredients
- Gallium ga-68 gozetotide — 5 mCi/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- UCLA Biomedical CyclotronNDC labeler code 76394
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212642
- Marketing start
- Listing expires
- Other FDA classes
- Positron Emitting Activity (Mechanism)
- Identifiers
- Product ID 76394-2642_2784e7a8-d4f1-fa61-e063-6394a90a614eSPL ID 2784e7a8-d4f1-fa61-e063-6394a90a614eSPL set ID 7744bafb-755e-29a2-e053-2991aa0a86a9UNII ZJ0EKR6M10
- Pharmacologic class
- Radioactive Diagnostic Agent
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.
- NDC on a medical claim
N476394264203followed by a unit qualifier and the quantityPackage 76394-2642-03. 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)
Gallium Ga 68 Gozetotide Injection 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. Gallium Ga 68 Gozetotide Injection 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 prostate-specific an…
Excerpt only. Read the full label for complete information.
About NDC 76394-2642
- What is NDC 76394-2642?
- 76394-2642 is the product NDC for Gallium Ga-68 PSMA-11 (gallium ga-68 gozetotide), Gallium ga-68 gozetotide 5 mCi/mL injection, solution, listed with the FDA by UCLA Biomedical Cyclotron. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gallium Ga-68 PSMA-11 (Gallium ga-68 gozetotide).
- What is the active ingredient?
- Gallium ga-68 gozetotide.
- Who is the labeler?
- UCLA Biomedical Cyclotron, NDC labeler code 76394. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gallium Ga-68 PSMA-11?
- 2 other product NDCs are listed under this name. See all Gallium Ga-68 PSMA-11 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gallium Ga-68 PSMA-11 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gallium Ga-68 PSMA-11gallium ga-68 gozetotide | Gallium ga-68 gozetotide 5 mCi/mL | Injection, SolutionIntravenous | Ionetix Corporation | 71162-201 | 71162-0201-10 |
| Gallium Ga-68 PSMA-11gallium ga-68 gozetotide | Gallium ga-68 gozetotide 5 mCi/mL | Injection, SolutionIntravenous | UCSF Radiopharmaceutical Facility | 24275-0525 | 24275-0525-01 |