Prescription drug · NDA
Dapzura Rt (daptomycin) NDC 60977-145
Daptomycin 500 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Dapzura Rt
- Generic name (nonproprietary)
- daptomycin
- Active ingredients
- Daptomycin — 500 mg/10mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213645
- Marketing start
- Listing expires
- Other FDA classes
- Lipopeptides (Chemical structure)
- Identifiers
- Product ID 60977-145_b5b302e0-d9e2-4032-ae95-cad85b08e130SPL ID b5b302e0-d9e2-4032-ae95-cad85b08e130SPL set ID cb1283e1-35b8-425c-b338-d9ac0c7161f8RxCUI 403920, 2591793UNII NWQ5N31VKK
- Pharmacologic class
- Lipopeptide Antibacterial
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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
DAPZURA RT is a lipopeptide antibacterial indicated for the treatment of: • Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) ( 1.1 ) and, • Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, ( 1.2 ) • Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). ( 1.3 ) Limitations of Use: • DAPZURA RT is not indicated for the treatment of pneumonia. ( 1.4 ) • DAPZURA RT is not indicated for the treatment of left-sided infective endocarditis due to S. aureus . ( 1.4 ) • DAPZURA RT is not recommended in pediat…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 213645
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Daptomycin in Sodium Chloride | Daptomycin 350 mg/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0712 |
| Daptomycin in Sodium Chloride | Daptomycin 500 mg/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0714 |
| Daptomycin in Sodium Chloride | Daptomycin 700 mg/100mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0716 |
| Daptomycin in Sodium Chloride | Daptomycin 1000 mg/100mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0718 |