Medicine
Daptomycin 500 mg/10 mL powder for injection
Daptomycin 500 mg/10 mL powder for injection is a generic prescription medicine for intravenous use, made by 19 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store original packages at 20°C to 25°C (68°F to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Daptomycin
- Brand
- Sold under the generic name
- Strength
- 500 mg/10 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial, 10 vials and 47 more
- Manufacturers
- Accord HealthcareIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaBioconIndiaEugiaIndiaSagent PharmaceuticalsHikma PharmaceuticalsMeitheal PharmaceuticalsXellia PharmaceuticalsBE Pharmaceuticals19 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store original packages at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Storage conditions for the reconstituted and diluted solutions are described in another section of the prescribing information.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01XX09 Daptomycin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 January 2018
- Identifiers
- RxCUI 403920, 1996246DailyMed set ID 74176769-b22e-4e41-8c56-051e15ec5fea, d6c3df37-8481-46c2-8048-199bad37c933, 4f39cddc-1cb7-41d4-a657-07f7903ee24f +37NDC 0143-9445, 68001-376, 71288-017 +34Application NDA217415, ANDA208375, ANDA213786 +19
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
A sample of 40 packs from 19 labelers. The register lists 50 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial in 1 carton / 7 mL in 1 vial | 16729-434-05 | Accord HealthcareIndia | 16 July 2019 |
| 10 vial in 1 carton / 7 mL in 1 vial | 16729-434-45 | Accord HealthcareIndia | 27 February 2020 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 16729-435-05 | Accord HealthcareIndia | 24 June 2019 |
| 1 vial, single-dose in 1 carton / 7 mL in 1 vial, single-dose | 31722-215-01 | Camber PharmaceuticalsIndia | 23 December 2022 |
| 10 vial, single-dose in 1 carton / 7 mL in 1 vial, single-dose | 31722-215-10 | Camber PharmaceuticalsIndia | 23 December 2022 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 31722-216-01 | Camber PharmaceuticalsIndia | 23 September 2022 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 43598-413-11 | Dr. Reddy's LaboratoriesIndia | 1 May 2019 |
| 1 vial, single-dose in 1 carton / 7 mL in 1 vial, single-dose | 43598-476-11 | Dr. Reddy's LaboratoriesIndia | 4 October 2021 |
| 10 vial, single-dose in 1 carton / 7 mL in 1 vial, single-dose | 43598-476-58 | Dr. Reddy's LaboratoriesIndia | 4 October 2021 |
| 1 vial, single-use in 1 carton / 10 mL in 1 vial, single-use | 70377-093-91 | BioconIndia | 25 October 2024 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 55150-344-01 | EugiaIndia | 2 September 2021 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 0143-9444-01 | Hikma Pharmaceuticals | 30 September 2025 |
| 1 vial, single-use in 1 carton / 10 mL in 1 vial, single-use | 0143-9445-01 | Hikma Pharmaceuticals | 11 December 2025 |
| 1 vial, single-use in 1 carton / 7 mL in 1 vial, single-use | 0143-9455-01 | Hikma Pharmaceuticals | 25 February 2026 |
| 1 vial, single-use in 1 carton / 7 mL in 1 vial, single-use | 0143-9456-01 | Hikma Pharmaceuticals | 22 October 2026 |
| 1 vial, single-use in 1 carton / 10 mL in 1 vial, single-use | 0143-9465-01 | Hikma Pharmaceuticals | 30 September 2025 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 71288-016-15 | Meitheal Pharmaceuticals | 29 June 2021 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 71288-016-91 | Meitheal Pharmaceuticals | 29 June 2021 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 71288-016-95 | Meitheal Pharmaceuticals | 29 June 2021 |
| 1 vial, single-dose in 1 carton / 7 mL in 1 vial, single-dose | 71288-017-15 | Meitheal Pharmaceuticals | 29 June 2021 |
| 1 vial, single-dose in 1 carton / 7 mL in 1 vial, single-dose | 71288-017-91 | Meitheal Pharmaceuticals | 5 April 2022 |
| 1 vial, single-use in 1 carton / 10 mL in 1 vial, single-use | 70594-034-01 | Xellia Pharmaceuticals | 1 October 2018 |
| 1 vial, single-use in 1 carton / 10 mL in 1 vial, single-use | 70594-034-02 | Xellia Pharmaceuticals | 1 May 2021 |
| 1 vial, single-use in 1 carton / 7 mL in 1 vial, single-use | 70594-053-01 | Xellia Pharmaceuticals | 15 March 2019 |
| 1 vial, single-use in 1 carton / 10 mL in 1 vial, single-use | 70594-060-01 | Xellia Pharmaceuticals | 3 November 2023 |
| 1 vial, single-use in 1 carton / 7 mL in 1 vial, single-use | 70594-066-01 | Xellia Pharmaceuticals | 3 November 2023 |
| 1 vial in 1 carton / 10 mL in 1 vial | 25021-174-15 | Sagent Pharmaceuticals | 15 November 2019 |
| 10 vial in 1 carton / 10 mL in 1 vial | 25021-174-16 | Sagent Pharmaceuticals | 15 November 2019 |
| 1 vial in 1 carton / 7 mL in 1 vial | 25021-179-15 | Sagent Pharmaceuticals | 15 January 2018 |
| 10 vial in 1 carton / 7 mL in 1 vial | 25021-179-16 | Sagent Pharmaceuticals | 15 January 2018 |
| 1 vial in 1 carton / 7 mL in 1 vial | 25021-179-66 | Sagent Pharmaceuticals | 1 February 2020 |
| 10 vial in 1 carton / 7 mL in 1 vial | 25021-179-67 | Sagent Pharmaceuticals | 1 February 2020 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 71839-107-01 | BE Pharmaceuticals | 26 June 2019 |
| 1 vial in 1 carton / 7 mL in 1 vial | 71839-108-01 | BE Pharmaceuticals | 20 August 2020 |
| 10 vial in 1 carton / 7 mL in 1 vial | 71839-108-10 | BE Pharmaceuticals | 20 August 2020 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 63323-371-10 | Fresenius Kabi | 11 April 2018 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 63323-371-19 | Fresenius Kabi | 11 April 2018 |
| 1 vial, single-dose in 1 carton / 7 mL in 1 vial, single-dose | 0409-0120-01 | Hospira | 2 August 2021 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 0409-0122-01 | Hospira | 2 August 2021 |
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 67457-813-50 | Mylan Institutional | 4 September 2018 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Daptomycin 500 mg/10 mL powder for injection.
Other strengths and forms of Daptomycin
Clinical summary
Daptomycin 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). MedsAcross supplies Daptomycin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about DaptomycinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Daptomycin prescribing information (Sagent Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Cubicin: European public assessment report (EPAR) · European Medicines Agency
- Daptomycin Hospira: European public assessment report (EPAR) · European Medicines Agency
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