Medicine
Levocetirizine 5 mg tablet
Levocetirizine 5 mg tablet is a generic prescription medicine for oral 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 at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Levocetirizine
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 500 tablets, 1000 tablets, 180 tablets and 87 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaCamber PharmaceuticalsIndiaMicro LabsIndiaGlenmark PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaBryant Ranch PrepackScieGen PharmaceuticalsVensun PharmaceuticalsTeva Pharmaceuticals19 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R06AE09 Levocetirizine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 February 2011
- Identifiers
- RxCUI 855172DailyMed set ID c79d3668-5243-4627-ad2b-cc7c045df120, f5d8d6a6-6455-430b-8923-090e1ca2ae3b, dd407f8f-140d-489f-b8c5-f6602d87e247 +35NDC 72162-1525, 10135-639, 31722-551 +35Application ANDA203646, ANDA202046, ANDA091264 +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 19 labelers. The register lists 90 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 500 tablet in 1 bottle | 31722-551-05 | Camber PharmaceuticalsIndia | 29 June 2012 |
| 1000 tablet in 1 bottle | 31722-551-10 | Camber PharmaceuticalsIndia | 29 June 2012 |
| 180 tablet in 1 bottle | 31722-551-18 | Camber PharmaceuticalsIndia | 29 June 2012 |
| 30 tablet in 1 bottle | 31722-551-30 | Camber PharmaceuticalsIndia | 29 June 2012 |
| 90 tablet in 1 bottle | 31722-551-90 | Camber PharmaceuticalsIndia | 29 June 2012 |
| 100 tablet, coated in 1 bottle | 55111-282-01 | Dr. Reddy's LaboratoriesIndia | 24 February 2011 |
| 500 tablet, coated in 1 bottle | 55111-282-05 | Dr. Reddy's LaboratoriesIndia | 24 February 2011 |
| 180 tablet, coated in 1 bottle | 55111-282-18 | Dr. Reddy's LaboratoriesIndia | 24 February 2011 |
| 30 tablet, coated in 1 bottle | 55111-282-30 | Dr. Reddy's LaboratoriesIndia | 24 February 2011 |
| 60 tablet, coated in 1 bottle | 55111-282-60 | Dr. Reddy's LaboratoriesIndia | 24 February 2011 |
| 10 blister pack in 1 carton / 10 tablet, coated in 1 blister pack | 55111-282-78 | Dr. Reddy's LaboratoriesIndia | 24 February 2011 |
| 90 tablet, coated in 1 bottle | 55111-282-90 | Dr. Reddy's LaboratoriesIndia | 24 February 2011 |
| 500 tablet in 1 bottle | 68462-346-05 | Glenmark PharmaceuticalsIndia | 1 September 2026 |
| 90 tablet in 1 bottle | 68462-346-90 | Glenmark PharmaceuticalsIndia | 25 February 2011 |
| 30 tablet, film coated in 1 bottle | 33342-200-07 | Macleods PharmaceuticalsIndia | 11 January 2016 |
| 90 tablet, film coated in 1 bottle | 33342-200-10 | Macleods PharmaceuticalsIndia | 11 January 2016 |
| 500 tablet, film coated in 1 bottle | 42571-122-05 | Micro LabsIndia | 30 September 2013 |
| 30 tablet, film coated in 1 bottle | 42571-122-30 | Micro LabsIndia | 30 September 2013 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 42571-122-32 | Micro LabsIndia | 30 September 2013 |
| 90 tablet, film coated in 1 bottle | 42571-122-90 | Micro LabsIndia | 30 September 2013 |
| 1000 tablet in 1 bottle | 50228-136-10 | ScieGen Pharmaceuticals | 9 September 2014 |
| 30 tablet in 1 bottle | 50228-136-30 | ScieGen Pharmaceuticals | 9 September 2014 |
| 90 tablet in 1 bottle | 50228-136-90 | ScieGen Pharmaceuticals | 9 September 2014 |
| 90 tablet, film coated in 1 bottle | 0093-7701-98 | Teva Pharmaceuticals | 6 September 2011 |
| 300 tablet in 1 bottle | 42543-712-03 | Vensun Pharmaceuticals | 27 October 2014 |
| 30 tablet in 1 bottle | 42543-712-30 | Vensun Pharmaceuticals | 27 October 2014 |
| 90 tablet in 1 bottle | 42543-712-90 | Vensun Pharmaceuticals | 27 October 2014 |
| 30 tablet in 1 bottle | 63629-8500-1 | Bryant Ranch Prepack | 18 May 2021 |
| 30 tablet, film coated in 1 bottle | 71335-0418-1 | Bryant Ranch Prepack | 30 August 2017 |
| 90 tablet, film coated in 1 bottle | 71335-0418-2 | Bryant Ranch Prepack | 30 August 2017 |
| 28 tablet, film coated in 1 bottle | 71335-0418-3 | Bryant Ranch Prepack | 30 August 2017 |
| 60 tablet, film coated in 1 bottle | 71335-0418-4 | Bryant Ranch Prepack | 30 August 2017 |
| 30 tablet in 1 bottle | 71335-0789-1 | Bryant Ranch Prepack | 11 January 2019 |
| 90 tablet in 1 bottle | 71335-0789-2 | Bryant Ranch Prepack | 17 May 2018 |
| 28 tablet in 1 bottle | 71335-0789-3 | Bryant Ranch Prepack | 27 December 2021 |
| 60 tablet in 1 bottle | 71335-0789-4 | Bryant Ranch Prepack | 27 December 2021 |
| 30 tablet in 1 bottle | 71335-0940-1 | Bryant Ranch Prepack | 30 August 2018 |
| 90 tablet in 1 bottle | 71335-0940-2 | Bryant Ranch Prepack | 30 August 2018 |
| 28 tablet in 1 bottle | 71335-0940-3 | Bryant Ranch Prepack | 30 August 2018 |
| 60 tablet in 1 bottle | 71335-0940-4 | Bryant Ranch Prepack | 30 August 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 25 May 2007 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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
Alternatives
Other makers and brands of Levocetirizine 5 mg tablet.
Other strengths and forms of Levocetirizine
Clinical summary
Levocetirizine is a histamine-1 receptor antagonist indicated for the relief of symptoms associated with perennial allergic rhinitis, among other approved uses. It is available as tablets and oral solution. MedsAcross supplies Levocetirizine 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 LevocetirizineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Xyzal prescribing information (Chattem) · U.S. National Library of Medicine, DailyMed
Need Levocetirizine 5 mg tablet for your hospital or patient?
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