Medicine
Hydroxyzine 25 mg capsule
Hydroxyzine 25 mg capsule is a generic prescription medicine for oral use, made by 25 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). Protect from moisture.
Key facts
- Active ingredient (INN)
- Hydroxyzine
- Brand
- Sold under the generic name
- Strength
- 25 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 120 capsules and 145 more
- Manufacturers
- Avet PharmaceuticalsIndiaBryant Ranch PrepackAmneal Pharmaceuticals of New YorkSandozTeva PharmaceuticalsChartwell RX25 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from moisture.
- 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
- 14 December 1981
- Identifiers
- RxCUI 995253, 995278, 995232DailyMed set ID c29f005e-ae75-415d-9fd6-591f074dcda5, 308cd178-a9d2-3132-e063-6394a90a7357, 2879c79f-bf2f-0bc9-e063-6394a90a98ae +37NDC 71610-747, 71610-883, 68071-3736 +37Application ANDA087479, ANDA201507, ANDA040156 +1
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 25 labelers. The register lists 148 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 container | 14539-674-01 | Avet PharmaceuticalsIndia | 23 April 2019 |
| 500 capsule in 1 container | 14539-674-05 | Avet PharmaceuticalsIndia | 23 April 2019 |
| 100 capsule in 1 bottle, plastic | 0115-1803-01 | Amneal Pharmaceuticals of New York | 15 July 1996 |
| 500 capsule in 1 bottle, plastic | 0115-1803-02 | Amneal Pharmaceuticals of New York | 15 July 1996 |
| 120 capsule in 1 bottle | 62135-816-12 | Chartwell RX | 6 February 2024 |
| 100 capsule in 1 bottle | 0185-0674-01 | Sandoz | 27 June 2014 |
| 500 capsule in 1 bottle | 0185-0674-05 | Sandoz | 27 June 2014 |
| 100 capsule in 1 bottle | 0555-0323-02 | Teva Pharmaceuticals | 1 July 1984 |
| 500 capsule in 1 bottle | 0555-0323-04 | Teva Pharmaceuticals | 1 July 1984 |
| 500 capsule in 1 bottle | 63629-8874-1 | Bryant Ranch Prepack | 27 June 2014 |
| 100 capsule in 1 bottle | 63629-9612-1 | Bryant Ranch Prepack | 23 January 2023 |
| 20 capsule in 1 bottle | 71335-0998-1 | Bryant Ranch Prepack | 31 August 2020 |
| 30 capsule in 1 bottle | 71335-0998-2 | Bryant Ranch Prepack | 12 November 2018 |
| 100 capsule in 1 bottle | 71335-0998-3 | Bryant Ranch Prepack | 28 December 2021 |
| 10 capsule in 1 bottle | 71335-0998-4 | Bryant Ranch Prepack | 28 December 2021 |
| 15 capsule in 1 bottle | 71335-0998-5 | Bryant Ranch Prepack | 27 November 2018 |
| 60 capsule in 1 bottle | 71335-0998-6 | Bryant Ranch Prepack | 30 September 2021 |
| 90 capsule in 1 bottle | 71335-0998-7 | Bryant Ranch Prepack | 16 September 2021 |
| 120 capsule in 1 bottle | 71335-0998-8 | Bryant Ranch Prepack | 28 December 2021 |
| 42 capsule in 1 bottle | 71335-0998-9 | Bryant Ranch Prepack | 28 December 2021 |
| 20 capsule in 1 bottle | 71335-1325-1 | Bryant Ranch Prepack | 28 August 2019 |
| 30 capsule in 1 bottle | 71335-1325-2 | Bryant Ranch Prepack | 28 August 2019 |
| 100 capsule in 1 bottle | 71335-1325-3 | Bryant Ranch Prepack | 19 September 2022 |
| 10 capsule in 1 bottle | 71335-1325-4 | Bryant Ranch Prepack | 19 September 2022 |
| 15 capsule in 1 bottle | 71335-1325-5 | Bryant Ranch Prepack | 19 September 2022 |
| 60 capsule in 1 bottle | 71335-1325-6 | Bryant Ranch Prepack | 22 December 2021 |
| 90 capsule in 1 bottle | 71335-1325-7 | Bryant Ranch Prepack | 30 September 2021 |
| 120 capsule in 1 bottle | 71335-1325-8 | Bryant Ranch Prepack | 19 September 2022 |
| 42 capsule in 1 bottle | 71335-1325-9 | Bryant Ranch Prepack | 19 September 2022 |
| 20 capsule in 1 bottle | 71335-1714-1 | Bryant Ranch Prepack | 7 May 2021 |
| 30 capsule in 1 bottle | 71335-1714-2 | Bryant Ranch Prepack | 15 October 2020 |
| 100 capsule in 1 bottle | 71335-1714-3 | Bryant Ranch Prepack | 29 December 2021 |
| 10 capsule in 1 bottle | 71335-1714-4 | Bryant Ranch Prepack | 29 December 2021 |
| 15 capsule in 1 bottle | 71335-1714-5 | Bryant Ranch Prepack | 29 December 2021 |
| 60 capsule in 1 bottle | 71335-1714-6 | Bryant Ranch Prepack | 14 July 2021 |
| 90 capsule in 1 bottle | 71335-1714-7 | Bryant Ranch Prepack | 19 March 2021 |
| 120 capsule in 1 bottle | 71335-1714-8 | Bryant Ranch Prepack | 29 December 2021 |
| 42 capsule in 1 bottle | 71335-1714-9 | Bryant Ranch Prepack | 29 December 2021 |
| 20 capsule in 1 bottle | 71335-2187-1 | Bryant Ranch Prepack | 7 November 2022 |
| 30 capsule in 1 bottle | 71335-2187-2 | Bryant Ranch Prepack | 7 November 2022 |
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 25 mg capsule 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.