Medicine
Levocetirizine 0.5 mg/mL oral solution
Levocetirizine 0.5 mg/mL oral solution is a generic prescription medicine for oral use, made by 4 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
- 0.5 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle, 148 mL and 2 more
- Manufacturers
- Camber PharmaceuticalsIndiaBryant Ranch PrepackChartwell RXPadagis Israel Pharmaceuticals
- 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
- 7 November 2011
- Identifiers
- RxCUI 855168DailyMed set ID 628c26f0-f6bb-4658-ba50-8ca04cd859cb, 2965ef46-18db-4615-9dce-bfb0f0b3366a, a9e7152c-0aa3-4355-8805-307e510ac86b +2NDC 63629-2533, 45802-680, 72162-1424 +2Application ANDA091263, ANDA210914, ANDA204599
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 bottle in 1 carton / 148 mL in 1 bottle | 31722-659-31 | Camber PharmaceuticalsIndia | 1 April 2019 |
| 148 mL in 1 bottle | 62135-917-38 | Chartwell RX | 30 August 2022 |
| 148 mL in 1 bottle | 45802-680-28 | Padagis Israel Pharmaceuticals | 7 November 2011 |
| 1 bottle in 1 carton / 148 mL in 1 bottle | 63629-2533-1 | Bryant Ranch Prepack | 7 November 2011 |
| 148 mL in 1 bottle | 72162-1424-2 | Bryant Ranch Prepack | 26 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.
| 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 0.5 mg/mL oral solution.
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 0.5 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.