Medicine
Hydroxyzine 10 mg/5 mL syrup
Hydroxyzine 10 mg/5 mL syrup is a generic prescription medicine for oral use, made by 3 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 Dispense in a tight, light-resistant…
Key facts
- Active ingredient (INN)
- Hydroxyzine
- Brand
- Sold under the generic name
- Strength
- 10 mg/5 mL
- Dosage form
- Syrup
- Route
- Oral
- Packs
- 2 trays, 473 mL, 118 mL and 1 more
- Manufacturers
- Chartwell RXChartwell Governmental & Specialty RXProficient Rx
- Origin register
- US FDA, United States
- Storage
- PROTECT FROM FREEZING PROTECT FROM LIGHT Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure. 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
- 12 April 1982
- Identifiers
- RxCUI 995241DailyMed set ID bcddc5ce-6cfb-4a09-8e6c-c956b65e3188, 53b2d731-f38a-47c0-9e5c-abd3b45e2fe1, 0de7a377-7a8f-4119-b172-1eadb4b7e1beNDC 63187-494, 62135-050, 68999-050 +1Application ANDA087294
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 |
|---|---|---|---|
| 2 tray in 1 box / 10 cup in 1 tray / 25 mL in 1 cup | 62135-050-24 | Chartwell RX | 23 September 2024 |
| 473 mL in 1 bottle | 62135-750-47 | Chartwell RX | 9 August 2023 |
| 2 tray in 1 box / 10 cup in 1 tray / 25 mL in 1 cup | 68999-050-24 | Chartwell Governmental & Specialty RX | 31 October 2025 |
| 118 mL in 1 bottle, plastic | 63187-494-04 | Proficient Rx | 2 February 2015 |
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 syrup 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.