Skip to content
MedsAcross

Medicine

Levofloxacin 500 mg tablet

Levofloxacin · Oral
Available on requestPrescription onlyUS FDAGeneric name

Levofloxacin 500 mg tablet is a generic prescription medicine for oral use, made by 27 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20° to 25°C (68° to 77°F) in well-closed containers.

Key facts

Active ingredient (INN)
Levofloxacin
Brand
Sold under the generic name
Strength
500 mg
Dosage form
Tablet
Route
Oral
Packs
10 blister pack, 50 tablets, 1000 tablets and 128 more
Manufacturers
Dr. Reddy's LaboratoriesIndiaMacleods PharmaceuticalsIndiaZydus LifesciencesIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaA-S Medication SolutionsRemedyrepackVerityrxChartwell RXNuCare Pharmaceuticals,Inc27 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F) in well-closed containers.
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
10 November 2010
Identifiers
RxCUI 199885, 199884, 311296DailyMed set ID b8defac4-9deb-433b-928e-0ef4ee0123a2, ac4001ca-882f-4d9b-a570-c1b9d7fd6830, 264a3f71-f23e-45e3-926a-421bcccf4e3d +36NDC 72789-085, 0904-6352, 70518-4568 +36Application ANDA201043, ANDA076710, ANDA077652 +4

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 27 labelers. The register lists 131 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack65862-537-10Aurobindo PharmaIndia20 June 2011
50 tablet, film coated in 1 bottle65862-537-50Aurobindo PharmaIndia20 June 2011
1000 tablet, film coated in 1 bottle65862-537-99Aurobindo PharmaIndia20 June 2011
10 tablet, film coated in 1 blister pack31722-722-31Camber PharmaceuticalsIndia9 January 2015
100 tablet, film coated in 1 blister pack31722-722-32Camber PharmaceuticalsIndia9 January 2015
50 tablet, film coated in 1 bottle31722-722-50Camber PharmaceuticalsIndia9 January 2015
100 tablet, film coated in 1 bottle55111-280-01Dr. Reddy's LaboratoriesIndia20 June 2011
500 tablet, film coated in 1 bottle55111-280-05Dr. Reddy's LaboratoriesIndia20 June 2011
30 tablet, film coated in 1 bottle55111-280-30Dr. Reddy's LaboratoriesIndia20 June 2011
50 tablet, film coated in 1 bottle55111-280-50Dr. Reddy's LaboratoriesIndia20 June 2011
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack55111-280-78Dr. Reddy's LaboratoriesIndia20 June 2011
50 tablet, film coated in 1 bottle33342-532-08Macleods PharmaceuticalsIndia22 March 2012
100 tablet, film coated in 1 bottle33342-532-11Macleods PharmaceuticalsIndia22 March 2012
100 tablet, film coated in 1 blister pack33342-532-12Macleods PharmaceuticalsIndia22 March 2012
50 tablet, film coated in 1 blister pack33342-532-31Macleods PharmaceuticalsIndia22 March 2012
100 tablet, film coated in 1 bottle65841-692-01Zydus LifesciencesIndia10 November 2012
500 tablet, film coated in 1 bottle65841-692-05Zydus LifesciencesIndia10 November 2012
1000 tablet, film coated in 1 bottle65841-692-10Zydus LifesciencesIndia10 November 2012
50 tablet, film coated in 1 bottle65841-692-18Zydus LifesciencesIndia10 November 2012
50 tablet in 1 bottle62135-656-50Chartwell RX19 January 2024
1 tablet, film coated in 1 pouch83939-0020-1Verityrx3 November 2025
50 pouch in 1 box, unit-dose / 1 tablet, film coated in 1 pouch83939-0020-2Verityrx3 November 2025
100 pouch in 1 box, unit-dose / 1 tablet, film coated in 1 pouch83939-0020-3Verityrx3 November 2025
30 tablet, film coated in 1 bottle, plastic70518-0453-3Remedyrepack13 May 2024
30 tablet, film coated in 1 blister pack70518-0587-0Remedyrepack26 June 2017
10 tablet, film coated in 1 bottle, plastic70518-0587-1Remedyrepack17 April 2019
7 tablet, film coated in 1 bottle, plastic70518-0587-2Remedyrepack29 May 2019
7 tablet, film coated in 1 blister pack70518-0587-3Remedyrepack29 July 2023
30 tablet, film coated in 1 bottle, plastic70518-0587-4Remedyrepack13 January 2025
10 tablet, film coated in 1 bottle, plastic70518-3712-0Remedyrepack12 April 2023
30 tablet, film coated in 1 blister pack70518-4568-0Remedyrepack4 February 2026
7 tablet, film coated in 1 bottle50090-1226-0A-S Medication Solutions28 November 2014
10 tablet, film coated in 1 bottle50090-1226-1A-S Medication Solutions28 November 2014
14 tablet, film coated in 1 bottle50090-1226-4A-S Medication Solutions28 November 2014
7 tablet, film coated in 1 bottle50090-3311-0A-S Medication Solutions1 February 2018
10 tablet, film coated in 1 bottle50090-3311-1A-S Medication Solutions22 December 2017
14 tablet, film coated in 1 bottle50090-3311-4A-S Medication Solutions5 February 2018
10 tablet, film coated in 1 bottle50090-3314-0A-S Medication Solutions28 December 2017
7 tablet, film coated in 1 bottle50090-3314-1A-S Medication Solutions30 October 2023
50 tablet, film coated in 1 bottle68071-3511-5NuCare Pharmaceuticals,Inc20 September 2023

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 20 December 1996Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

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 Levofloxacin

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Levofloxacin 500 mg tablet 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.