Medicine
Xyzal 0.5 mg/mL oral solution
Xyzal 0.5 mg/mL oral solution is a prescription medicine containing Levocetirizine for oral use, marketed by Chattem, 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 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC…
Key facts
- Active ingredient (INN)
- Levocetirizine
- Brand
- Xyzal
- Strength
- 0.5 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Chattem
- Manufacturer
- Chattem
- Origin register
- US FDA, United States
- Storage
- Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (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 July 2017
- Identifiers
- RxCUI 855168, 855170, 855172 +1DailyMed set ID 1673f7ff-0c7c-4403-86cf-c05eb1475222NDC 41167-5804Application NDA022064
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 148 mL in 1 bottle | 41167-5804-5 | Chattem | 24 July 2017 |
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 Xyzal 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.