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MedsAcross

Medicine

Ondansetron 16 mg tablet

Ondansetron · Oral
Available on requestPrescription onlyUS FDAGeneric name

Ondansetron 16 mg tablet is a generic prescription medicine for oral use, 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°-25°C (68°-77°F). Store blisters in cartons.

Key facts

Active ingredient (INN)
Ondansetron
Brand
Sold under the generic name
Strength
16 mg
Dosage form
Tablet
Route
Oral
Packs
500 tablets, 30 tablets, 10 blister pack
Manufacturer
Dr. Reddy's LaboratoriesIndia
Origin register
US FDA, United States
Storage
Store at 20°-25°C (68°-77°F). Store blisters in cartons.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
A04AA01 Ondansetron
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
26 December 2006
Identifiers
RxCUI 692695DailyMed set ID 476e704c-95ae-4591-94f7-ee4ab827ff13NDC 55111-155Application ANDA076183

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

PackCodeLabelerMarketed since
500 tablet, film coated in 1 bottle55111-155-05Dr. Reddy's LaboratoriesIndia26 December 2006
30 tablet, film coated in 1 bottle55111-155-30Dr. Reddy's LaboratoriesIndia26 December 2006
10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack55111-155-78Dr. Reddy's LaboratoriesIndia26 December 2006

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 4 January 1991Drugs@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 Ondansetron

Clinical summary

Ondansetron is a serotonin-3 receptor antagonist. It is available as tablets, orally disintegrating tablets and injection for intramuscular and intravenous use. MedsAcross supplies Ondansetron 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 Ondansetron

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

Data sources

Need Ondansetron 16 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.