Prescription drug · ANDA
daptomycin NDC 67457-941
Daptomycin 500 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-941-15 | 6745709411567457094115 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-941-15) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 27, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Mylan Institutional LLCNDC labeler code 67457
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213966
- Marketing start
- Listing expires
- Other FDA classes
- Lipopeptides (Chemical structure)
- Identifiers
- Product ID 67457-941_9298852c-a9c3-4787-8dec-919dd666c968SPL ID 9298852c-a9c3-4787-8dec-919dd666c968SPL set ID 95909792-972b-4c0c-b2ce-2be4bed36cffRxCUI 403920UNII 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
N467457094115followed by a unit qualifier and the quantityPackage 67457-0941-15. 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 )…
Excerpt only. Read the full label for complete information.
About NDC 67457-941
- What is NDC 67457-941?
- 67457-941 is the product NDC for daptomycin, Daptomycin 500 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- daptomycin.
- What is the active ingredient?
- Daptomycin.
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for daptomycin?
- 41 other product NDCs are listed under this name. See all daptomycin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other daptomycin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Daptomycin | Daptomycin 350 mg/7mL | Injection, Powder, Lyophilized, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9455 | 00143-9455-01 |
| Daptomycin | Daptomycin 500 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9445 | 00143-9445-01 |
| Daptomycin | Daptomycin 350 mg/7mL | Injection, Powder, Lyophilized, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9456 | 00143-9456-01 |
| Daptomycin | Daptomycin 500 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Civica, Inc. | 72572-158 | 72572-0158-01 |
| Daptomycin | Daptomycin 500 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Par Health USA, LLC | 42023-295 | 42023-0295-10 |
| Daptomycin | Daptomycin 500 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9444 | 00143-9444-01 |
| Daptomycin | Daptomycin 500 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9465 | 00143-9465-01 |
| Daptomycin | Daptomycin 500 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | MAIA Pharmaceuticals, Inc. | 70511-182 | 70511-0182-84 |
| Daptomycin | Daptomycin 500 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Biocon Pharma Inc. | 70377-093 | 70377-0093-91 |
| daptomycin | Daptomycin 500 mg/20mL | Injection, Powder, Lyophilized, For suspensionIntravenous | Hainan Poly Pharm., Co., Ltd. | 14335-120 | 14335-0120-01 |