Medicine
Hydroxyzine 50 mg tablet
Hydroxyzine 50 mg tablet is a generic prescription medicine for oral use, made by 31 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° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Hydroxyzine
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 121 more
- Manufacturers
- Aurobindo PharmaIndiaAvet PharmaceuticalsIndiaCamber PharmaceuticalsIndiaBryant Ranch PrepackChartwell RXAmneal PharmaceuticalsEpic PharmaKVK-TechRising Pharma HoldingsSunrise Pharmaceutical31 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°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
- 29 May 2008
- Identifiers
- RxCUI 995281, 995218, 995258DailyMed set ID a8c83479-f919-49f9-b125-747bd0e3211c, 214b3f14-2f6c-4f36-b7a6-e0b1f820e3a7, 44c63e67-a9e0-4a4f-b34e-2ca60a981766 +37NDC 72162-2513, 72789-269, 72789-378 +37Application ANDA087871, ANDA088619, ANDA204279 +9
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 31 labelers. The register lists 124 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 59651-501-01 | Aurobindo PharmaIndia | 7 October 2021 |
| 500 tablet, film coated in 1 bottle | 59651-501-05 | Aurobindo PharmaIndia | 7 October 2021 |
| 1000 tablet, film coated in 1 bottle | 59651-501-99 | Aurobindo PharmaIndia | 7 October 2021 |
| 100 tablet in 1 bottle | 23155-502-01 | Avet PharmaceuticalsIndia | 20 August 2014 |
| 500 tablet in 1 bottle | 23155-502-05 | Avet PharmaceuticalsIndia | 20 August 2014 |
| 1000 tablet in 1 bottle | 23155-502-10 | Avet PharmaceuticalsIndia | 20 August 2014 |
| 100 tablet, film coated in 1 bottle | 31722-502-01 | Camber PharmaceuticalsIndia | 29 May 2008 |
| 500 tablet, film coated in 1 bottle | 31722-502-05 | Camber PharmaceuticalsIndia | 29 May 2008 |
| 1000 tablet, film coated in 1 bottle | 31722-502-10 | Camber PharmaceuticalsIndia | 29 May 2008 |
| 500 tablet, film coated in 1 bottle | 62135-547-05 | Chartwell RX | 28 June 2023 |
| 120 tablet, film coated in 1 bottle | 62135-547-12 | Chartwell RX | 28 June 2023 |
| 500 tablet in 1 bottle | 62135-575-05 | Chartwell RX | 11 April 2023 |
| 120 tablet in 1 bottle | 62135-575-12 | Chartwell RX | 11 April 2023 |
| 100 tablet, film coated in 1 bottle | 65162-577-10 | Amneal Pharmaceuticals | 24 September 2008 |
| 1000 tablet, film coated in 1 bottle | 65162-577-11 | Amneal Pharmaceuticals | 24 September 2008 |
| 500 tablet, film coated in 1 bottle | 65162-577-50 | Amneal Pharmaceuticals | 24 September 2008 |
| 1000 tablet, film coated in 1 bottle | 24658-783-10 | Blu Pharmaceuticals | 21 July 2021 |
| 100 tablet, film coated in 1 bottle | 42806-161-01 | Epic Pharma | 31 March 2015 |
| 500 tablet, film coated in 1 bottle | 42806-161-05 | Epic Pharma | 31 March 2015 |
| 1000 tablet, film coated in 1 bottle | 42806-161-10 | Epic Pharma | 31 March 2015 |
| 100 tablet, film coated in 1 bottle | 10702-012-01 | KVK-Tech | 24 July 2012 |
| 1000 tablet, film coated in 1 bottle | 10702-012-10 | KVK-Tech | 24 July 2012 |
| 500 tablet, film coated in 1 bottle | 10702-012-50 | KVK-Tech | 24 July 2012 |
| 100 tablet, film coated in 1 bottle | 16571-115-01 | Rising Pharma Holdings | 22 August 2023 |
| 1000 tablet, film coated in 1 bottle | 16571-115-10 | Rising Pharma Holdings | 22 August 2023 |
| 500 tablet, film coated in 1 bottle | 16571-115-50 | Rising Pharma Holdings | 22 August 2023 |
| 100 tablet, film coated in 1 bottle | 11534-206-01 | Sunrise Pharmaceutical | 1 May 2024 |
| 1000 tablet, film coated in 1 bottle | 11534-206-03 | Sunrise Pharmaceutical | 1 May 2024 |
| 500 tablet, film coated in 1 bottle | 11534-206-04 | Sunrise Pharmaceutical | 10 January 2025 |
| 100 tablet, film coated in 1 bottle | 0093-5062-01 | Teva Pharmaceuticals | 11 March 2013 |
| 500 tablet, film coated in 1 bottle | 0093-5062-05 | Teva Pharmaceuticals | 22 October 2012 |
| 120 tablet, film coated in 1 bottle | 63629-4929-1 | Bryant Ranch Prepack | 20 August 2014 |
| 20 tablet, film coated in 1 bottle | 63629-4929-2 | Bryant Ranch Prepack | 20 August 2014 |
| 30 tablet, film coated in 1 bottle | 63629-4929-3 | Bryant Ranch Prepack | 20 August 2014 |
| 60 tablet, film coated in 1 bottle | 63629-4929-4 | Bryant Ranch Prepack | 20 August 2014 |
| 90 tablet, film coated in 1 bottle | 63629-4929-5 | Bryant Ranch Prepack | 20 August 2014 |
| 120 tablet, film coated in 1 bottle | 71335-0246-1 | Bryant Ranch Prepack | 4 October 2017 |
| 20 tablet, film coated in 1 bottle | 71335-0246-2 | Bryant Ranch Prepack | 4 October 2017 |
| 30 tablet, film coated in 1 bottle | 71335-0246-3 | Bryant Ranch Prepack | 4 October 2017 |
| 60 tablet, film coated in 1 bottle | 71335-0246-4 | Bryant Ranch Prepack | 4 October 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 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 50 mg tablet 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.