Prescription drug · ANDA
Kit for the Preparation of Technetium Tc99m Sestamibi NDC 65857-500
Technetium tc-99m sestamibi 1 mg/5mL · Injection, Powder, Lyophilized, For solution · Parenteral · Cardinal Health 414, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65857-500-20 | 65857050020 | 20 VIAL in 1 CARTON (65857-500-20) / 5 mL in 1 VIALMarketed from Jun 1, 2010 |
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)
- Kit for the Preparation of Technetium Tc99m Sestamibi
- Generic name (nonproprietary)
- kit for the preparation of technetium tc99m sestamibi
- Active ingredients
- Technetium tc-99m sestamibi — 1 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Parenteral
- Labeler
- Cardinal Health 414, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078809
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 65857-500_a5589464-e5bb-47b5-8a0c-372df1d7aed5SPL ID a5589464-e5bb-47b5-8a0c-372df1d7aed5SPL set ID 8626e756-767a-4a14-9188-658b58185254UNII 971Z4W1S09
- 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.
- NDC on a medical claim
N465857050020followed by a unit qualifier and the quantityPackage 65857-0500-20. 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)
Myocardial Imaging: Technetium Tc 99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc 99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent’s labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarctio…
Excerpt only. Read the full label for complete information.