Quick answers
- What is Daptomycin used for?
- The FDA-approved label (Daptomycin, Sagent Pharmaceuticals, August 6, 2026) says: “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) and, Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Daptomycin have a boxed warning?
- No. None of the 45 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Daptomycin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Daptomycin been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started August 6, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Daptomycin?
- 25 companies list prescription products of Daptomycin in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., Baxter Healthcare Corporation and Xellia Pharmaceuticals USA LLC.
What Daptomycin is used for
Quoted from the “Indications and Usage” section of the FDA-approved 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) and, Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis, Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 …
— FDA label: Daptomycin, Sagent Pharmaceuticals, effective August 6, 2026. Read the full label on DailyMed →
The FDA has 45 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 45 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Injection, solution · Injection, powder, lyophilized, for suspension |
|---|---|
| Route | Intravenous |
| Prescription products | 47 in the FDA NDC Directory |
| Brand names | Dapzura Rt |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| daptomycin 50 mg/mL injection, powder, lyophilized, for solution | Generic | $25.56 per unit |
| daptomycin 500 mg/10 mL injection, powder, lyophilized, for solution | Generic | $25.56 per unit |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hikma Pharmaceuticals USA Inc.5 products
- Baxter Healthcare Corporation5 products
- Xellia Pharmaceuticals USA LLC5 products
- Meitheal Pharmaceuticals Inc.5 products
- Sagent Pharmaceuticals3 products
- Civica, Inc.3 products
- Mylan Institutional LLC2 products
- BE Pharmaceuticals Inc.2 products
- Hospira, Inc.2 products
- Accord Healthcare Inc.2 products
- Camber Pharmaceuticals, Inc.2 products
- Dr. Reddy's Laboratories Inc.2 products
- NorthStar RxLLC2 products
- Fresenius Kabi USA, LLC2 products
- Sintetica US LLC1 product
- Aspiro Pharma Limited1 product
- BluePoint Laboratories1 product
- Eugia US LLC1 product
- MAIA Pharmaceuticals, Inc.1 product
- Slate Run Pharmaceuticals, LLC1 product
- Par Health USA, LLC1 product
- Qilu Pharmaceutical Co., Ltd.1 product
- Biocon Pharma Inc.1 product
- Hainan Poly Pharm. Co., Ltd.1 product
- Apotex Corp.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208385 DAPTOMYCIN | Sagent Pharms Inc | September 12, 2017 | 5, latest April 30, 2025 2025: Labeling · 2022: Labeling · 2022: Labeling |
| NDA209949 DAPTOMYCIN | Hikma | October 20, 2017 | 5, latest April 30, 2025 2025: Labeling · 2023: Labeling · 2021: Efficacy |
| NDA210282 DAPTOMYCIN | Hospira | June 21, 2021 | 2, latest April 30, 2025 2025: Labeling · 2022: Labeling |
| NDA213645 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE, DAPZURA RT | Baxter Hlthcare Corp | January 25, 2022 | 3, latest September 24, 2026 2026: Labeling · 2025: Labeling · 2023: Efficacy |
| NDA217415 DAPTOMYCIN | Hikma | January 30, 2023 | 2, latest April 30, 2025 2025: Labeling · 2025: Labeling |
| NDA217630 DAPTOMYCIN | Maia Pharms Inc | November 21, 2024 | — |
Generic approvals (19)
- ANDA206005Xellia Pharms Aps · June 15, 2016
- ANDA206077Fresenius Kabi USA · April 11, 2018
- ANDA205037Mylan Labs Ltd · June 5, 2018
- ANDA208375DR Reddys · May 1, 2019
- ANDA211961Accord Hlthcare · June 24, 2019
- ANDA212513Be Pharms · June 26, 2019
- ANDA212667Accord Hlthcare · July 12, 2019
- ANDA207104Sagent Pharms Inc · November 15, 2019
- ANDA213425Be Pharms · August 20, 2020
- ANDA211403DR Reddys · August 31, 2020
- ANDA213623Meitheal · June 29, 2021
- ANDA213786Meitheal · June 29, 2021
- ANDA215316Qilu Pharm Hainan · August 24, 2021
- ANDA213171Eugia Pharma · September 2, 2021
- ANDA215890Hainan Poly Pharm · August 18, 2022
- ANDA216413Aspiro · September 23, 2022
- ANDA216445Aspiro · December 23, 2022
- ANDA213966Mylan · August 7, 2023
- ANDA217215Biocon Pharma · August 29, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 6, 2026 · Class II · Ongoing · D-0821-2026
CGMP Deviations
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC — Baxter Healthcare Corporation
-
August 6, 2026 · Class II · Ongoing · D-0807-2026
CGMP Deviations
Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 — Baxter Healthcare Corporation
-
February 7, 2023 · Class II · Terminated · D-0382-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-435-05 UPC 3 16729 43505 5. — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0381-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b) 10 Single-dose vials NDC 16729-434-45 UPC 3 16729 43445 4 Manufactured by: Intas Pharmaceuticals Li — Accord Healthcare, Inc.
-
July 7, 2020 · Class I · Terminated · D-1484-2020
Presence of Particulate Matter
Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50 — Mylan Institutional LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 403920, 1996246, 2591793 |
|---|---|
| SPL set ID of the quoted label | 4a0ad110-e55e-4d3b-84f8-dd0b924fe2f6 |
| FDA labels (SPL) | 45 |
| FDA applications | NDA208385, NDA209949, NDA210282, NDA213645, NDA217415, NDA217630, 19 ANDA |
| Active ingredients (FDA) | DAPTOMYCIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Daptomycin, Sagent Pharmaceuticals, effective August 6, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →