Prescription drug · NDA
Daptomycin NDC 0409-0122
Daptomycin 500 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-0122-01 | 00409012201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0122-01) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 2, 2021 |
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 — 500 mg/10mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Hospira, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210282
- Marketing start
- Listing expires
- Other FDA classes
- Lipopeptides (Chemical structure)
- Identifiers
- Product ID 0409-0122_70737bda-cf0c-42f1-89bc-d47e321d2218SPL ID 70737bda-cf0c-42f1-89bc-d47e321d2218SPL set ID 1957b6ce-7382-4a7b-bf02-3595948d09c6RxCUI 403920, 1996246UNII 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
N400409012201followed by a unit qualifier and the quantityPackage 00409-0122-01. 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 patients ( 1.1 ) and, • Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, ( 1.2 ) Limitations of Use: • This Daptomycin for Injection product is not approved for use in pediatric patients. ( 1.3 ) • Daptomycin for Injection is not indicated for the treatment of pneumonia. ( 1.3 ) • Daptomycin for Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus . ( 1.3 ) • Daptomycin for Injection is not recommended in pediat…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 210282
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 | Hospira, Inc. | 0409-0120 |