Medicine
Hydroxyzine 50 mg capsule
Hydroxyzine 50 mg capsule is a generic prescription medicine for oral use, made by 20 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
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 120 capsules and 55 more
- Manufacturers
- Avet PharmaceuticalsIndiaBryant Ranch PrepackRemedyrepackA-S Medication SolutionsAmneal Pharmaceuticals of New YorkNorthwind HealthNuCare Pharmaceuticals,IncSandozTeva PharmaceuticalsChartwell RX20 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
- 14 December 1981
- Identifiers
- RxCUI 995253, 995278, 995232DailyMed set ID 734d32c8-38d3-430f-a2b3-539e03a3687a, bc82aaaf-30c7-4afe-a908-d138ea1268ef, c38cfd32-2562-4d6c-8a2e-d9984c16d9eb +24NDC 14539-675, 0115-1804, 0185-0676 +24Application ANDA201507, ANDA040156, ANDA086183 +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 20 labelers. The register lists 58 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule in 1 container | 14539-675-01 | Avet PharmaceuticalsIndia | 23 April 2019 |
| 500 capsule in 1 container | 14539-675-05 | Avet PharmaceuticalsIndia | 23 April 2019 |
| 100 capsule in 1 bottle, plastic | 0115-1804-01 | Amneal Pharmaceuticals of New York | 15 June 1996 |
| 500 capsule in 1 bottle, plastic | 0115-1804-02 | Amneal Pharmaceuticals of New York | 15 June 1996 |
| 120 capsule in 1 bottle | 62135-817-12 | Chartwell RX | 6 February 2024 |
| 100 capsule in 1 bottle | 0185-0676-01 | Sandoz | 14 September 2021 |
| 500 capsule in 1 bottle | 0185-0676-05 | Sandoz | 14 September 2021 |
| 100 capsule in 1 bottle | 0555-0302-02 | Teva Pharmaceuticals | 1 July 1984 |
| 500 capsule in 1 bottle | 0555-0302-04 | Teva Pharmaceuticals | 1 July 1984 |
| 30 capsule in 1 bottle | 71335-1265-1 | Bryant Ranch Prepack | 29 July 2019 |
| 60 capsule in 1 bottle | 71335-1265-2 | Bryant Ranch Prepack | 17 May 2024 |
| 90 capsule in 1 bottle | 71335-1265-3 | Bryant Ranch Prepack | 17 May 2024 |
| 8 capsule in 1 bottle | 71335-1265-4 | Bryant Ranch Prepack | 17 May 2024 |
| 20 capsule in 1 bottle | 71335-1265-5 | Bryant Ranch Prepack | 24 June 2019 |
| 42 capsule in 1 bottle | 71335-1265-6 | Bryant Ranch Prepack | 6 January 2020 |
| 30 capsule in 1 bottle, plastic | 71335-1923-1 | Bryant Ranch Prepack | 20 January 2022 |
| 60 capsule in 1 bottle, plastic | 71335-1923-2 | Bryant Ranch Prepack | 14 February 2022 |
| 90 capsule in 1 bottle, plastic | 71335-1923-3 | Bryant Ranch Prepack | 11 January 2022 |
| 8 capsule in 1 bottle, plastic | 71335-1923-4 | Bryant Ranch Prepack | 14 February 2022 |
| 20 capsule in 1 bottle, plastic | 71335-1923-5 | Bryant Ranch Prepack | 14 February 2022 |
| 42 capsule in 1 bottle, plastic | 71335-1923-6 | Bryant Ranch Prepack | 14 February 2022 |
| 30 capsule in 1 bottle | 71335-2076-1 | Bryant Ranch Prepack | 25 April 2022 |
| 60 capsule in 1 bottle | 71335-2076-2 | Bryant Ranch Prepack | 25 April 2022 |
| 90 capsule in 1 bottle | 71335-2076-3 | Bryant Ranch Prepack | 25 April 2022 |
| 8 capsule in 1 bottle | 71335-2076-4 | Bryant Ranch Prepack | 25 April 2022 |
| 20 capsule in 1 bottle | 71335-2076-5 | Bryant Ranch Prepack | 25 April 2022 |
| 42 capsule in 1 bottle | 71335-2076-6 | Bryant Ranch Prepack | 25 April 2022 |
| 20 capsule in 1 bottle | 50090-5933-1 | A-S Medication Solutions | 2 January 2024 |
| 12 capsule in 1 bottle | 50090-7540-0 | A-S Medication Solutions | 23 April 2025 |
| 20 capsule in 1 bottle | 50090-7540-1 | A-S Medication Solutions | 23 April 2025 |
| 30 capsule in 1 bottle, plastic | 51655-252-52 | Northwind Health | 25 April 2023 |
| 30 capsule in 1 bottle, plastic | 82868-046-30 | Northwind Health | 19 February 2024 |
| 90 capsule in 1 bottle | 66267-556-90 | NuCare Pharmaceuticals,Inc | 12 February 2024 |
| 90 capsule in 1 container | 68071-3583-9 | NuCare Pharmaceuticals,Inc | 6 March 2024 |
| 30 capsule in 1 blister pack | 70518-3232-3 | Remedyrepack | 31 March 2023 |
| 100 pouch in 1 box / 1 capsule in 1 pouch | 70518-3232-4 | Remedyrepack | 5 December 2023 |
| 30 capsule in 1 blister pack | 70518-3232-7 | Remedyrepack | 24 June 2024 |
| 21 capsule in 1 blister pack | 70518-4463-0 | Remedyrepack | 30 August 2025 |
| 30 capsule in 1 blister pack | 70518-4463-1 | Remedyrepack | 11 September 2025 |
| 30 capsule in 1 blister pack | 87441-041-01 | Unit Dose Solutions | 24 June 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 50 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.