Prescription drug · NDA
CardioGen-82 (rubidium chloride rb-82) NDC 0270-0091
Rubidium chloride rb-82 150 mCi/1 · Injection, Solution · Intravenous · Bracco Diagnostics Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0270-0091-01 | 00270009101 | 1 INJECTION, SOLUTION in 1 PACKAGE (0270-0091-01)Marketed from Dec 30, 1989 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- CardioGen-82
- Generic name (nonproprietary)
- rubidium chloride rb-82
- Active ingredients
- Rubidium chloride rb-82 — 150 mCi/1
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Bracco Diagnostics Inc
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019414
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 0270-0091_754d36d0-0bf7-4bb2-8864-1667468b9116SPL ID 754d36d0-0bf7-4bb2-8864-1667468b9116SPL set ID ee95aa18-9f2f-40eb-9b4c-583bea6f36bfUNII F0Z746KRKQ
- 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
N400270009101followed by a unit qualifier and the quantityPackage 00270-0091-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
CardioGen-82, used to produce Rubidium Chloride Rb 82 Injection, is indicated for positron emission tomography (PET) of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease. CardioGen-82, used to produce Rubidium Chloride Rb 82 Injection, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease. ( 1 )
Excerpt only. Read the full label for complete information.