Prescription drug · ANDA
Ammonia N 13 (ammonia n-13) NDC 40028-514
Ammonia n-13 260 mCi/mL · Injection · Intravenous · PETNET Solutions, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 40028-514-50 | 40028051450 | 50 mL in 1 VIAL, GLASS (40028-514-50)Marketed from Feb 1, 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)
- Ammonia N 13
- Generic name (nonproprietary)
- ammonia n-13
- Active ingredients
- Ammonia n-13 — 260 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- PETNET Solutions, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204510
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 40028-514_4513e87e-72fd-96e1-e063-6394a90a9273SPL ID 4513e87e-72fd-96e1-e063-6394a90a9273SPL set ID b1559f8a-1fc8-4a9e-b4f4-5e2efcb1f12cUNII 9OQO0E343Z
- 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
N440028051450followed by a unit qualifier and the quantityPackage 40028-0514-50. 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)
Ammonia N 13 Injection is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease. Ammonia N 13 Injection is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease ( 1 ).
Excerpt only. Read the full label for complete information.