Prescription drug · NDA
Daptomycin NDC 0143-9455
Daptomycin 350 mg/7mL · Injection, Powder, Lyophilized, For solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9455-01 | 00143945501 | 1 VIAL, SINGLE-USE in 1 CARTON (0143-9455-01) / 7 mL in 1 VIAL, SINGLE-USEMarketed from Feb 25, 2026 |
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
- Generic name (nonproprietary)
- daptomycin
- Active ingredients
- Daptomycin — 350 mg/7mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209949
- Marketing start
- Listing expires
- Other FDA classes
- Lipopeptides (Chemical structure)
- Identifiers
- Product ID 0143-9455_34a28940-21e7-4056-9ab8-dfac30198662SPL ID 34a28940-21e7-4056-9ab8-dfac30198662SPL set ID 23f39005-3008-4ab1-918d-b8acb001554eRxCUI 1996246UNII NWQ5N31VKKUPC 0301439455011
- 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
N400143945501followed by a unit qualifier and the quantityPackage 00143-9455-01. 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)
Daptomycin for 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) ( 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: Daptomycin for Injection is not indicated for the treatment of pneumonia. ( 1.4 ) Daptomycin for Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. ( 1.4 ) Daptomycin…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 209949
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 | Daptomycin 350 mg/7mL | Injection, Powder, Lyophilized, For solutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-053 |
| Daptomycin | Daptomycin 350 mg/7mL | Injection, Powder, Lyophilized, For solutionIntravenous | Civica, Inc. | 72572-100 |