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MedsAcross

Medicine

Meclizine 50 mg tablet

Meclizine · Oral
Available on requestPrescription onlyUS FDAGeneric name

Meclizine 50 mg tablet is a generic prescription medicine for oral use, made by 6 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

Available on request

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), excursions permitted between 15° to 30°C…

Key facts

Active ingredient (INN)
Meclizine
Brand
Sold under the generic name
Strength
50 mg
Dosage form
Tablet
Route
Oral
Packs
500 tablets, 90 tablets, 100 tablets and 12 more
Manufacturers
Aurobindo PharmaIndiaAvet PharmaceuticalsIndiaAmneal PharmaceuticalsAsclemedChartwell RXRising Pharma Holdings
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°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 666dc4d8-7b16-4c3c-84e4-645548dbee68, e6a5df4b-5cbf-4a0c-b38a-f4509c9c17db, c9ddc39c-bc6b-42f1-8c5f-5aff2d79c4bd +3NDC 65162-444, 76420-799, 16571-662 +3Application ANDA201451, NDA010721, ANDA205136 +2

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.

PackCodeLabelerMarketed since
500 tablet in 1 bottle59651-809-05Aurobindo PharmaIndia14 September 2023
90 tablet in 1 bottle59651-809-90Aurobindo PharmaIndia14 September 2023
100 tablet in 1 bottle23155-943-01Avet PharmaceuticalsIndia25 June 2026
1000 tablet in 1 package23155-943-10Avet PharmaceuticalsIndia25 June 2026
30 tablet in 1 bottle65162-444-03Amneal Pharmaceuticals12 February 2010
100 tablet in 1 bottle65162-444-10Amneal Pharmaceuticals12 February 2010
1000 tablet in 1 bottle65162-444-11Amneal Pharmaceuticals12 February 2010
500 tablet in 1 bottle65162-444-50Amneal Pharmaceuticals12 February 2010
100 tablet in 1 blister pack65162-444-60Amneal Pharmaceuticals12 February 2010
60 tablet, film coated in 1 bottle62135-954-60Chartwell RX4 March 2025
100 tablet in 1 bottle16571-662-01Rising Pharma Holdings15 January 2020
100 tablet in 1 bottle76420-799-01Asclemed5 April 2024
30 tablet in 1 bottle76420-799-30Asclemed5 April 2024
60 tablet in 1 bottle76420-799-60Asclemed5 April 2024
90 tablet in 1 bottle76420-799-90Asclemed5 April 2024

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 14 February 1957Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 Meclizine

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Meclizine 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.