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NDC 63323-0371-19 Daptomycin 500 mg/10mL Details
Daptomycin 500 mg/10mL
Daptomycin is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is DAPTOMYCIN.
MedlinePlus Drug Summary
Daptomycin injection is used to treat certain blood infections or serious skin infections caused by bacteria in adults and children 1 year of age and older. Daptomycin injection is in a class of medications called cyclic lipopeptide antibiotics. It works by killing bacteria. Antibiotics such as daptomycin injection will not work for treating colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 63323-0371-19Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Daptomycin Injection
Product Information
| NDC | 63323-0371 |
|---|---|
| Product ID | 63323-371_b1854217-71fa-48a4-9279-928e663eb5ec |
| Associated GPIs | 16270030002140 |
| GCN Sequence Number | 053190 |
| GCN Sequence Number Description | daptomycin VIAL 500 MG INTRAVEN |
| HIC3 | W9B |
| HIC3 Description | CYCLIC LIPOPEPTIDES |
| GCN | 20569 |
| HICL Sequence Number | 025673 |
| HICL Sequence Number Description | DAPTOMYCIN |
| Brand/Generic | Generic |
| Proprietary Name | Daptomycin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Daptomycin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/10mL |
| Substance Name | DAPTOMYCIN |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Lipopeptide Antibacterial [EPC], Lipopeptides [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206077 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0371-19 (63323037119)
| NDC Package Code | 63323-371-19 |
|---|---|
| Billing NDC | 63323037119 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-371-19) / 10 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2018-04-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |