Prescription drug · NDA
Daptomycin in Sodium Chloride NDC 0338-0714
Daptomycin 500 mg/50mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-0714-24 | 00338071424 | 24 BAG in 1 CARTON (0338-0714-24) / 50 mL in 1 BAGMarketed from Feb 27, 2023 |
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)
- Daptomycin in Sodium Chloride
- Generic name (nonproprietary)
- daptomycin in sodium chloride
- Active ingredients
- Daptomycin — 500 mg/50mL
- Dosage form
- Injection, 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 0338-0714_7b6f75eb-02dd-4906-9ee1-4c658a5e36b3SPL ID 7b6f75eb-02dd-4906-9ee1-4c658a5e36b3SPL set ID 7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecefRxCUI 2632127, 2632130, 2632132, 2632133UNII 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.
- NDC on a medical claim
N400338071424followed by a unit qualifier and the quantityPackage 00338-0714-24. 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)
Daptomycin in Sodium Chloride Injection 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) for whom appropriate dosing can be achieved ( 1.1 ) and, • Staphylococcus aureus bloodstream infections (bacteremia), in adult patients for whom appropriate dosing can be achieved, including those with right-sided infective endocarditis, ( 1.2 ) • Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved. ( 1.3 ) Limitations of Use • Daptomycin in Sodium Chloride Injection is not indicated for…
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 |
|---|---|---|---|---|
| Dapzura Rtdaptomycin | Daptomycin 500 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Baxter Healthcare Corporation | 60977-145 |
| Daptomycin in Sodium Chloride | Daptomycin 350 mg/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0712 |
| 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 |