Prescription drug · ANDA
Ammonia N 13 (Ammonia n-13) NDC 49609-003
Ammonia n-13 260 mCi/mL · Injection · Intravenous · SOFIE Co. dba SOFIE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49609-003-01 | 4960900030149609000301 | 30 mL in 1 VIAL, GLASS (49609-003-01)Marketed from Aug 4, 2011 |
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 13Suffix: N 13
- Generic name (nonproprietary)
- ammonia n-13
- Active ingredients
- Ammonia n-13 — 260 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- SOFIE Co. dba SOFIENDC labeler code 49609
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203543
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 49609-003_31e5cc40-daff-bea7-e063-6294a90a5aa4SPL ID 31e5cc40-daff-bea7-e063-6294a90a5aa4SPL set ID 85882893-0661-46c2-a5f2-a73f6ea4fb5aUNII 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
N449609000301followed by a unit qualifier and the quantityPackage 49609-0003-01. 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 49609-003
- What is NDC 49609-003?
- 49609-003 is the product NDC for Ammonia N 13 (ammonia n-13), Ammonia n-13 260 mCi/mL injection, listed with the FDA by SOFIE Co. dba SOFIE. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ammonia N 13 (Ammonia n-13).
- What is the active ingredient?
- Ammonia n-13.
- Who is the labeler?
- SOFIE Co. dba SOFIE, NDC labeler code 49609. 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-13 260 mCi/mL | InjectionIntravenous | The Methodist Hospital Research Institute | 69864-002 | 69864-0002-30 |
| 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 |