Medicine
Meclizine 12.5 mg tablet
Meclizine 12.5 mg tablet is a generic prescription medicine for oral use, made by 18 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 • C to 25 • C (68 • F to 77 • F).
Key facts
- Active ingredient (INN)
- Meclizine
- Brand
- Sold under the generic name
- Strength
- 12.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1000 tablets, 100 tablets, 30 tablets and 67 more
- Manufacturers
- Zydus LifesciencesIndiaAurobindo PharmaIndiaBryant Ranch PrepackAmneal PharmaceuticalsAmneal Pharmaceuticals of New YorkEpic PharmaRising Pharma HoldingsChartwell RX18 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20 • C to 25 • C (68 • F to 77 • F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 February 2010
- Identifiers
- RxCUI 995624, 995666, 995686 +1DailyMed set ID 467e464b-bbaf-4053-9136-39e47a92fa05, af1e45ca-1478-4eeb-8fdc-4f3d3eda4ed5, 52ee9258-8311-e6bd-e063-6294a90a567f +20NDC 42806-012, 60687-775, 67296-2250 +20Application ANDA200294, ANDA201451, ANDA202640 +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
A sample of 40 packs from 18 labelers. The register lists 70 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1000 tablet in 1 bottle | 70710-1161-0 | Zydus LifesciencesIndia | 29 October 2020 |
| 100 tablet in 1 bottle | 70710-1161-1 | Zydus LifesciencesIndia | 29 October 2020 |
| 30 tablet in 1 bottle | 70710-1161-3 | Zydus LifesciencesIndia | 29 October 2020 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70710-1161-4 | Zydus LifesciencesIndia | 29 October 2020 |
| 90 tablet in 1 bottle | 70710-1161-9 | Zydus LifesciencesIndia | 29 October 2020 |
| 1000 tablet in 1 bottle | 70771-1539-0 | Zydus LifesciencesIndia | 29 October 2020 |
| 100 tablet in 1 bottle | 70771-1539-1 | Zydus LifesciencesIndia | 29 October 2020 |
| 30 tablet in 1 bottle | 70771-1539-3 | Zydus LifesciencesIndia | 29 October 2020 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70771-1539-4 | Zydus LifesciencesIndia | 29 October 2020 |
| 90 tablet in 1 bottle | 70771-1539-9 | Zydus LifesciencesIndia | 29 October 2020 |
| 100 tablet in 1 bottle | 59651-807-01 | Aurobindo PharmaIndia | 14 September 2023 |
| 1000 tablet in 1 bottle | 59651-807-99 | Aurobindo PharmaIndia | 14 September 2023 |
| 30 tablet in 1 bottle | 65162-441-03 | Amneal Pharmaceuticals | 12 February 2010 |
| 100 tablet in 1 bottle | 65162-441-10 | Amneal Pharmaceuticals | 12 February 2010 |
| 1000 tablet in 1 bottle | 65162-441-11 | Amneal Pharmaceuticals | 12 February 2010 |
| 500 tablet in 1 bottle | 65162-441-50 | Amneal Pharmaceuticals | 12 February 2010 |
| 100 tablet in 1 blister pack | 65162-441-60 | Amneal Pharmaceuticals | 12 February 2010 |
| 100 tablet in 1 bottle | 53746-441-01 | Amneal Pharmaceuticals of New York | 22 April 2022 |
| 1000 tablet in 1 bottle | 53746-441-10 | Amneal Pharmaceuticals of New York | 22 April 2022 |
| 90 tablet, film coated in 1 bottle | 62135-952-90 | Chartwell RX | 4 March 2025 |
| 100 tablet in 1 bottle | 42806-012-01 | Epic Pharma | 30 April 2012 |
| 1000 tablet in 1 bottle | 42806-012-10 | Epic Pharma | 30 April 2012 |
| 100 tablet in 1 bottle | 16571-660-01 | Rising Pharma Holdings | 15 January 2020 |
| 500 tablet in 1 bottle | 16571-660-50 | Rising Pharma Holdings | 15 January 2020 |
| 30 tablet in 1 bottle | 71335-1563-1 | Bryant Ranch Prepack | 4 June 2010 |
| 60 tablet in 1 bottle | 71335-1563-2 | Bryant Ranch Prepack | 4 June 2010 |
| 90 tablet in 1 bottle | 71335-1563-3 | Bryant Ranch Prepack | 4 June 2010 |
| 28 tablet in 1 bottle | 71335-1563-4 | Bryant Ranch Prepack | 4 June 2010 |
| 20 tablet in 1 bottle | 71335-1563-5 | Bryant Ranch Prepack | 4 June 2010 |
| 120 tablet in 1 bottle | 71335-1563-6 | Bryant Ranch Prepack | 4 June 2010 |
| 100 tablet in 1 bottle | 71335-1563-7 | Bryant Ranch Prepack | 4 June 2010 |
| 30 tablet in 1 bottle | 71335-1872-1 | Bryant Ranch Prepack | 28 June 2021 |
| 60 tablet in 1 bottle | 71335-1872-2 | Bryant Ranch Prepack | 28 June 2021 |
| 90 tablet in 1 bottle | 71335-1872-3 | Bryant Ranch Prepack | 28 June 2021 |
| 28 tablet in 1 bottle | 71335-1872-4 | Bryant Ranch Prepack | 28 June 2021 |
| 20 tablet in 1 bottle | 71335-1872-5 | Bryant Ranch Prepack | 28 June 2021 |
| 120 tablet in 1 bottle | 71335-1872-6 | Bryant Ranch Prepack | 28 June 2021 |
| 100 tablet in 1 bottle | 71335-1872-7 | Bryant Ranch Prepack | 28 June 2021 |
| 10 tablet in 1 bottle | 71335-1872-8 | Bryant Ranch Prepack | 28 June 2021 |
| 1000 tablet in 1 bottle | 71335-3139-1 | Bryant Ranch Prepack | 27 May 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 14 February 1957 | 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 Meclizine
Clinical summary
Meclizine is an antiemetic indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. It is available as tablets and chewable tablets for oral use. MedsAcross supplies Meclizine 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 MeclizineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Meclizine Hydrochloride prescribing information (Rising Pharma Holdings) · U.S. National Library of Medicine, DailyMed
Need Meclizine 12.5 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.