Medicine
Cetirizine 1 mg/mL oral solution
Cetirizine 1 mg/mL oral solution is a generic prescription medicine for oral use, made by 15 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F), or…
Key facts
- Active ingredient (INN)
- Cetirizine
- Brand
- Sold under the generic name
- Strength
- 1 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 120 mL, 473 mL, 1 bottle and 26 more
- Manufacturers
- Avet Pharmaceuticals LabsIndiaSun Pharmaceutical IndustriesIndiaBajaj MedicalApozeal PharmaceuticalsPreferred PharmaceuticalsAmneal PharmaceuticalsBionpharmaChartwell RXPAI PharmaRising Pharma Holdings
- Origin register
- US FDA, United States
- Storage
- Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F), or Store refrigerated, 2°-8°C (36°-46°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R06AE07 Cetirizine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 July 2008
- Identifiers
- RxCUI 1014673DailyMed set ID e874264a-becc-45d0-b934-779eab5f5085, 0956baea-f0ad-4aac-9464-831840db9230, e626bd59-dd18-465c-b740-9d04eb48c28e +15NDC 68788-8523, 72888-480, 50090-5220 +14Application ANDA078398, ANDA220335, ANDA076601 +6
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 |
|---|---|---|---|
| 120 mL in 1 bottle | 23155-929-51 | Avet Pharmaceuticals LabsIndia | 1 March 2025 |
| 473 mL in 1 bottle | 23155-929-52 | Avet Pharmaceuticals LabsIndia | 1 March 2025 |
| 1 bottle in 1 carton / 120 mL in 1 bottle | 51672-4070-8 | Sun Pharmaceutical IndustriesIndia | 1 May 2014 |
| 120 mL in 1 bottle, plastic | 61037-479-02 | Bajaj Medical | 12 September 2023 |
| 480 mL in 1 bottle, plastic | 61037-479-03 | Bajaj Medical | 16 July 2024 |
| 240 mL in 1 bottle, plastic | 61037-479-04 | Bajaj Medical | 6 June 2025 |
| 5 mL in 1 cup, unit-dose | 61037-479-06 | Bajaj Medical | 6 June 2025 |
| 5 mL in 1 box, unit-dose | 61037-479-12 | Bajaj Medical | 6 June 2025 |
| 120 mL in 1 bottle | 72888-480-01 | Advagen Pharma | 25 February 2026 |
| 118 mL in 1 bottle | 65162-684-86 | Amneal Pharmaceuticals | 7 October 2009 |
| 473 mL in 1 bottle | 65162-684-90 | Amneal Pharmaceuticals | 7 October 2009 |
| 120 mL in 1 bottle | 83745-185-04 | Apozeal Pharmaceuticals | 20 December 2024 |
| 240 mL in 1 bottle | 83745-185-08 | Apozeal Pharmaceuticals | 20 December 2024 |
| 480 mL in 1 bottle | 83745-185-16 | Apozeal Pharmaceuticals | 20 December 2024 |
| 120 mL in 1 bottle | 69206-990-01 | Aventura Pharmaceuticals | 1 February 2023 |
| 120 mL in 1 bottle | 69452-426-55 | Bionpharma | 1 December 2025 |
| 480 mL in 1 bottle | 69452-426-88 | Bionpharma | 1 December 2025 |
| 120 mL in 1 bottle | 62135-057-41 | Chartwell RX | 8 June 2022 |
| 473 mL in 1 bottle | 62135-057-47 | Chartwell RX | 8 June 2022 |
| 1 bottle in 1 carton / 120 mL in 1 bottle | 45802-626-26 | Padagis Israel Pharmaceuticals | 24 July 2008 |
| 120 mL in 1 bottle | 0121-0874-04 | PAI Pharma | 21 June 2024 |
| 480 mL in 1 bottle | 0121-0874-16 | PAI Pharma | 12 February 2024 |
| 120 mL in 1 bottle, plastic | 16571-134-12 | Rising Pharma Holdings | 16 July 2024 |
| 480 mL in 1 bottle, plastic | 16571-134-48 | Rising Pharma Holdings | 16 July 2024 |
| 1 bottle in 1 carton / 120 mL in 1 bottle | 68788-8282-1 | Preferred Pharmaceuticals | 25 October 2023 |
| 1 bottle in 1 carton / 120 mL in 1 bottle | 68788-8523-1 | Preferred Pharmaceuticals | 13 September 2023 |
| 120 mL in 1 bottle | 68788-8890-1 | Preferred Pharmaceuticals | 27 June 2025 |
| 1 bottle in 1 carton / 120 mL in 1 bottle | 50090-5220-0 | A-S Medication Solutions | 7 October 2020 |
| 1 bottle in 1 carton / 120 mL in 1 bottle | 71205-435-04 | Proficient Rx | 19 March 2020 |
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 8 December 1995 | 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
Other strengths and forms of Cetirizine
Clinical summary
Cetirizine is a histamine-1 receptor antagonist indicated for the treatment of ocular itching associated with allergic conjunctivitis. It is available as oral solution, injection and powder for ophthalmic solution for intravenous use. MedsAcross supplies Cetirizine 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 CetirizineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ZERVIATE prescribing information (Harrow Eye) · U.S. National Library of Medicine, DailyMed
Need Cetirizine 1 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.