Medicine
Levofloxacin 500 mg/20 mL injection
Levofloxacin 500 mg/20 mL injection is a generic prescription medicine for intravenous use, made by 3 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
Each vial contains a clear yellow to a clear greenish yellow concentrated…
Key facts
- Active ingredient (INN)
- Levofloxacin
- Brand
- Sold under the generic name
- Strength
- 500 mg/20 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 20 mL, 20 mL
- Manufacturers
- EugiaIndiaGland PharmaIndiaBaxter Healthcare
- Origin register
- US FDA, United States
- Storage
- Each vial contains a clear yellow to a clear greenish yellow concentrated solution with the equivalent of 500 mg of levofloxacin in 20 mL vials and 750 mg of levofloxacin in 30 mL vials. 500 mg (25 mg/mL), 20 mL vials in a carton of 1 NDC 55150-156-20 750 mg (25 mg/mL), 30 mL vials in a carton of 1 NDC 55150-157-30 Levofloxacin injection in single-dose vials should be stored at 20° to 25°C (68°…
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01MA12 Ofloxacin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 January 2013
- Identifiers
- RxCUI 1665517, 1665519, 1665497 +2DailyMed set ID 4d400bf9-988f-42ec-93f1-e71a93a324b2, 70c87464-1806-480a-8ebd-3f02987ff436, ba69722b-d7f2-4519-8a63-9ee91294c499NDC 55150-156, 36000-045, 68083-394Application ANDA202328, ANDA091436, ANDA205540
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, single-use in 1 carton / 20 mL in 1 vial, single-use | 55150-156-20 | EugiaIndia | 24 January 2013 |
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 68083-394-01 | Gland PharmaIndia | 22 April 2020 |
| 20 mL in 1 vial, single-use | 36000-045-01 | Baxter Healthcare | 1 July 2013 |
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
Other strengths and forms of Levofloxacin
Clinical summary
Levofloxacin is a fluoroquinolone antibacterial indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. MedsAcross supplies Levofloxacin 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 LevofloxacinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Levofloxacin prescribing information (Sagent Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Quinsair: European public assessment report (EPAR) · European Medicines Agency
Need Levofloxacin 500 mg/20 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.