Prescription drug · ANDA
Gallium Ga-68 PSMA-11 (Gallium ga-68 gozetotide) NDC 71162-201
Gallium ga-68 gozetotide 5 mCi/mL · Injection, Solution · Intravenous · Ionetix Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71162-201-10 | 71162020110 | 9 mL in 1 SYRINGE (71162-201-10)Marketed from Jan 17, 2024 |
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)
- 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
- Ionetix CorporationNDC labeler code 71162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219189
- Marketing start
- Listing expires
- Other FDA classes
- Positron Emitting Activity (Mechanism)
- Identifiers
- Product ID 71162-201_51ca091b-2dd4-d547-e063-6394a90a4fb8SPL ID 51ca091b-2dd4-d547-e063-6394a90a4fb8SPL set ID 357655a4-b3ee-4ea1-a1ea-50d4686546bbUNII 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
N471162020110followed by a unit qualifier and the quantityPackage 71162-0201-10. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 71162-201
- What is NDC 71162-201?
- 71162-201 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 Ionetix Corporation. 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?
- Ionetix Corporation, NDC labeler code 71162. 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 | UCSF Radiopharmaceutical Facility | 24275-0525 | 24275-0525-01 |
| Gallium Ga-68 PSMA-11gallium ga-68 gozetotide | Gallium ga-68 gozetotide 5 mCi/mL | Injection, SolutionIntravenous | UCLA Biomedical Cyclotron | 76394-2642 | 76394-2642-03 |