Medicine
Hydroxyzine 10 mg/5 mL oral solution
Hydroxyzine 10 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 10 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
PROTECT FROM FREEZING PROTECT FROM LIGHT Store at 20°C to 25°C (68°F to 77°F)…
Key facts
- Active ingredient (INN)
- Hydroxyzine
- Brand
- Sold under the generic name
- Strength
- 10 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 473 mL, 72 cup, 40 cup and 8 more
- Manufacturers
- Kesin PharmaAdvagen PharmaANI PharmaceuticalsApozeal PharmaceuticalsAtlantic BiologicalsBionpharmaChartwell RXLannettPAI PharmaSaptalis Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- PROTECT FROM FREEZING PROTECT FROM LIGHT 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
- N05BB01 Hydroxyzine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 April 2002
- Identifiers
- RxCUI 995241DailyMed set ID 4b094d1b-97b2-6ca6-e063-6294a90a2437, a4fb61ae-aad6-4bd6-83fc-8b227f175df9, 2a343906-0bea-4bd8-bd35-c3f199d9b266 +7NDC 81033-031, 54838-502, 0121-1034 +7Application ANDA219289, ANDA201674, ANDA040391 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 473 mL in 1 bottle | 72888-218-13 | Advagen Pharma | 11 September 2026 |
| 473 mL in 1 bottle | 70954-912-10 | ANI Pharmaceuticals | 15 January 2026 |
| 473 mL in 1 bottle | 83745-232-16 | Apozeal Pharmaceuticals | 16 July 2024 |
| 473 mL in 1 bottle | 69452-395-88 | Bionpharma | 17 July 2025 |
| 473 mL in 1 bottle | 62135-502-47 | Chartwell RX | 3 October 2022 |
| 473 mL in 1 bottle, plastic | 54838-502-80 | Lannett | 21 August 2013 |
| 473 mL in 1 bottle | 0121-1034-16 | PAI Pharma | 14 November 2024 |
| 473 mL in 1 bottle | 71656-090-16 | Saptalis Pharmaceuticals | 17 June 2026 |
| 72 cup, unit-dose in 1 box, unit-dose / 5 mL in 1 cup, unit-dose | 17856-0507-1 | Atlantic Biologicals | 8 May 2024 |
| 40 cup, unit-dose in 1 carton / 5 mL in 1 cup, unit-dose | 81033-031-44 | Kesin Pharma | 27 February 2026 |
| 40 cup, unit-dose in 1 carton / 12.5 mL in 1 cup, unit-dose | 81033-031-45 | Kesin Pharma | 27 February 2026 |
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 12 April 1956 | 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 Hydroxyzine
Clinical summary
Hydroxyzine is an antihistamine. It is available as tablets, capsules and oral solution for intramuscular use. MedsAcross supplies Hydroxyzine 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 HydroxyzineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Hydroxyzine Hydrochloride prescribing information (Advagen Pharma) · U.S. National Library of Medicine, DailyMed
Need Hydroxyzine 10 mg/5 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.