Prescription drug · ANDA
Daptomycin NDC 16729-434
Daptomycin 350 mg/7mL · Injection, Powder, Lyophilized, For solution · Intravenous · Accord Healthcare, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-434-05 | 1672904340516729043405 | 1 VIAL in 1 CARTON (16729-434-05) / 7 mL in 1 VIALMarketed from Jul 16, 2019 | |
| 16729-434-45 | 1672904344516729043445 | 10 VIAL in 1 CARTON (16729-434-45) / 7 mL in 1 VIALMarketed from Feb 27, 2020 |
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 — 350 mg/7mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Accord Healthcare, Inc.NDC labeler code 16729
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212667
- Marketing start
- Listing expires
- Other FDA classes
- Lipopeptides (Chemical structure)
- Identifiers
- Product ID 16729-434_40bc42f7-4d83-0e17-e063-6394a90ad5d2SPL ID 40bc42f7-4d83-0e17-e063-6394a90ad5d2SPL set ID f69e9306-ffac-41c9-b277-a6d784f2e341RxCUI 1996246UNII NWQ5N31VKKUPC 0316729434058, 0316729434454
- 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
N416729043405followed by a unit qualifier and the quantityPackage 16729-0434-05. 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 ) Daptomyci…
Excerpt only. Read the full label for complete information.
About NDC 16729-434
- What is NDC 16729-434?
- 16729-434 is the product NDC for Daptomycin, Daptomycin 350 mg/7mL injection, powder, lyophilized, for solution, listed with the FDA by Accord Healthcare, Inc.. It has 2 package NDCs, 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?
- Accord Healthcare, Inc., NDC labeler code 16729. 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/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 67457-941 | 67457-0941-15 |