Medicine
RotaTeq oral solution
RotaTeq oral solution is a prescription medicine containing Rotavirus vaccine, live, oral, pentavalent for oral use, marketed by Merck Sharp & Dohme, 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
Storage as on the product label
Key facts
- Active ingredient (INN)
- Rotavirus vaccine, live, oral, pentavalent
- Brand
- RotaTeq
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 25 pouches, 10 pouches, 10 ampules
- Marketing authorisation holder
- Merck Sharp & Dohme
- Manufacturer
- Merck Sharp & Dohme
- Origin register
- US FDA, United States
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.41Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 February 2006
- Identifiers
- NDC 0006-4379, 0006-4047Application BLA125122
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 25 pouch in 1 carton / 1 tube in 1 pouch / 2 mL in 1 tube | 0006-4047-20 | Merck Sharp & Dohme | 3 February 2006 |
| 10 pouch in 1 carton / 1 tube in 1 pouch / 2 mL in 1 tube | 0006-4047-41 | Merck Sharp & Dohme | 3 February 2006 |
| 10 ampule in 1 carton / 2 mL in 1 ampule | 0006-4379-02 | Merck Sharp & Dohme | 15 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 |
| 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
Clinical summary
Clinical information for Rotavirus vaccine, live, oral, pentavalent is on its overview page.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Rotavirus vaccine, live, oral, pentavalentFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- US FDA NDC directory · Checked 12 November 2026
Need RotaTeq oral solution 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.