Prescription drug · NDA
Kit for the Preparation of Technetium Tc 99M Medronate (Tc 99m medronate) NDC 45567-0040
Technetium tc-99m medronate 20 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45567-0040-1 | 4556700400145567004001 | 5 VIAL, MULTI-DOSE in 1 KIT (45567-0040-1) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Aug 29, 1979 | |
| 45567-0040-2 | 4556700400245567004002 | 30 VIAL, MULTI-DOSE in 1 KIT (45567-0040-2) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Aug 29, 1979 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Tc 99M Medronate
- Generic name (nonproprietary)
- tc 99m medronate
- Active ingredients
- Technetium tc-99m medronate — 20 mg/10mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 45567
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018124
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 45567-0040_3010d5a9-2402-c30a-e063-6394a90a73abSPL ID 3010d5a9-2402-c30a-e063-6394a90a73abSPL set ID 703d347c-e240-408a-b69d-9713e958a201UNII X89XV46R07
- 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
N445567004001followed by a unit qualifier and the quantityPackage 45567-0040-01. 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)
INDICATIONS AND USAGE: Technetium Tc 99m Medronate Injection may be used as a bone imaging agent to delineate areas of altered osteogenesis.
Excerpt only. Read the full label for complete information.
About NDC 45567-0040
- What is NDC 45567-0040?
- 45567-0040 is the product NDC for Kit for the Preparation of Technetium Tc 99M Medronate, Technetium tc-99m medronate 20 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kit for the Preparation of Technetium Tc 99M Medronate (Tc 99m medronate).
- What is the active ingredient?
- Technetium tc-99m medronate.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 45567. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kit for the Preparation of Technetium Tc 99M Medronate?
- 1 other product NDC are listed under this name. See all Kit for the Preparation of Technetium Tc 99M Medronate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Kit for the Preparation of Technetium Tc 99M Medronate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Kit for the Preparation of Technetium Tc 99m Medronatetechnetium tc 99m medronate | Technetium tc-99m medronate 20 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Cardinal Health 414, LLC | 65857-505 | 65857-0505-10 |