Prescription drug · ANDA
Ammonia N-13 NDC 69864-002
Ammonia n-13 260 mCi/mL · Injection · Intravenous · The Methodist Hospital Research Institute
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69864-002-30 | 6986400023069864000230 | 6 mL in 1 VIAL, GLASS (69864-002-30)Marketed from Jul 9, 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)
- Ammonia N-13
- Generic name (nonproprietary)
- ammonia n-13
- Active ingredients
- Ammonia n-13 — 260 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- The Methodist Hospital Research InstituteNDC labeler code 69864
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215083
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 69864-002_0ce4c7b6-2913-fecf-e063-6394a90ab438SPL ID 0ce4c7b6-2913-fecf-e063-6394a90ab438SPL set ID c79222b1-7dd8-f1fe-e053-2a95a90a3639UNII 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
N469864000230followed by a unit qualifier and the quantityPackage 69864-0002-30. 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.
About NDC 69864-002
- What is NDC 69864-002?
- 69864-002 is the product NDC for Ammonia N-13, Ammonia n-13 260 mCi/mL injection, listed with the FDA by The Methodist Hospital Research Institute. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ammonia N-13.
- What is the active ingredient?
- Ammonia n-13.
- Who is the labeler?
- The Methodist Hospital Research Institute, NDC labeler code 69864. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ammonia N-13?
- 18 other product NDCs are listed under this name. See all Ammonia N-13 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ammonia N-13 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ammonia N 13 | Ammonia n-13 37.5 mCi/mL | InjectionIntravenous | University of Wisconsin System | 72333-001 | 72333-0001-10 |
| Ammonia N 13ammonia n-13 | Ammonia n-13 37.5 mCi/mL | Injection, SolutionIntravenous | The University of Texas Southwestern Medical Center | 70681-001 | 70681-0001-30 |
| Ammonia N 13 | Ammonia n-13 37.5 mCi/mL | InjectionIntravenous | SOFIE Co. dba SOFIE | 73410-001 | 73410-0001-01 |
| Ammonia N 13ammonia n-13 | Ammonia n-13 37.5 mCi/mL | InjectionIntravenous | Ionetix Corporation | 71162-001 | 71162-0001-05 |
| Ammonia N 13ammonia n-13 | Ammonia n-13 37.5 mCi/mL | Injection, SolutionIntravenous | Massachusetts General Hospital | 76318-643 | 76318-0643-30 |
| Ammonia N 13ammonia n-13 | Ammonia n-13 37.5 mCi/mL | Injection, SolutionIntravenous | Biomedical Research Foundation of Northwest Louisiana | 24562-004 | 24562-0004-30 |
| Ammonia N-13 | Ammonia n-13 37.5 mCi/mL | InjectionIntravenous | Brigham and Women's Hospital, Inc., The | 24450-113 | 24450-0113-10 |
| Ammonia N 13ammonia n-13 | Ammonia n-13 37.5 mCi/mL | InjectionIntravenous | Kreitchman PET Center | 62072-456 | 62072-0456-56 |
| Ammonia N 13ammonia n-13 | Ammonia n-13 37.5 mCi/mL | Injection, SolutionIntravenous | Mayo Clinic | 52670-552 | 52670-0552-30 |
| Ammonia N-13 | Ammonia n-13 37.5 mCi/mL | InjectionIntravenous | Cardinal Health 414, LLC | 65857-200 | 65857-0200-10 |