Medicine
Levofloxacin 25 mg/mL oral solution
Levofloxacin 25 mg/mL oral solution is a generic prescription medicine for oral use, made by 2 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
Levofloxacin Oral Solution, USP should be stored at 25°C (77°F), excursions…
Key facts
- Active ingredient (INN)
- Levofloxacin
- Brand
- Sold under the generic name
- Strength
- 25 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 100 mL, 200 mL, 480 mL and 3 more
- Manufacturers
- ANI PharmaceuticalsLannett
- Origin register
- US FDA, United States
- Storage
- Levofloxacin Oral Solution, USP should be stored at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [refer to USP controlled room temperature].
- 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
- 25 May 2018
- Identifiers
- RxCUI 477391DailyMed set ID a894e40b-77e4-439b-b0f8-9a5cc7a1dd90, 362fb864-3afb-4841-a7c4-b64b1346aba0NDC 70954-852, 0527-1948Application ANDA091678, ANDA205222
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 |
|---|---|---|---|
| 100 mL in 1 bottle | 70954-852-10 | ANI Pharmaceuticals | 26 March 2024 |
| 200 mL in 1 bottle | 70954-852-20 | ANI Pharmaceuticals | 26 March 2024 |
| 480 mL in 1 bottle | 70954-852-30 | ANI Pharmaceuticals | 26 March 2024 |
| 1 bottle, plastic in 1 carton / 100 mL in 1 bottle, plastic | 0527-1948-66 | Lannett | 25 May 2018 |
| 1 bottle, plastic in 1 carton / 200 mL in 1 bottle, plastic | 0527-1948-68 | Lannett | 25 May 2018 |
| 1 bottle, plastic in 1 carton / 480 mL in 1 bottle, plastic | 0527-1948-70 | Lannett | 25 May 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
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 25 mg/mL oral solution 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.