Medicine
Ibu 800 mg tablet
Ibu 800 mg tablet is a prescription medicine containing Ibuprofen for oral use, marketed by Dr. Reddy's Laboratories, 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 room temperature. Avoid excessive heat 40°C (104°F).
Key facts
- Active ingredient (INN)
- Ibuprofen
- Brand
- Ibu
- Strength
- 800 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 90 tablets and 15 more
- Marketing authorisation holder
- Dr. Reddy's Laboratories
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaAphena Pharma Solutions - TennesseeNuCare Pharmaceuticals,Inc
- Origin register
- US FDA, United States
- Storage
- Store at room temperature. Avoid excessive heat 40°C (104°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01EB16 Ibuprofen
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 November 2001
- Identifiers
- RxCUI 197807, 206917, 197805 +3DailyMed set ID 678e2d16-33f3-67a7-e053-2991aa0a1132, ffec2f44-1144-4729-b43a-1db40ea6a8d3, 24731405-219c-79b4-ecf0-7d5fbfda94ba +2NDC 68071-3053, 71610-275, 55111-684 +2Application ANDA075682
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 55111-684-01 | Dr. Reddy's LaboratoriesIndia | 20 November 2008 |
| 500 tablet in 1 bottle | 55111-684-05 | Dr. Reddy's LaboratoriesIndia | 20 November 2008 |
| 90 tablet in 1 bottle | 55111-684-09 | Dr. Reddy's LaboratoriesIndia | 20 November 2008 |
| 30 tablet in 1 bottle | 55111-684-30 | Dr. Reddy's LaboratoriesIndia | 20 November 2008 |
| 50 tablet in 1 bottle | 55111-684-50 | Dr. Reddy's LaboratoriesIndia | 20 November 2008 |
| 60 tablet in 1 bottle | 55111-684-60 | Dr. Reddy's LaboratoriesIndia | 20 November 2008 |
| 90 tablet in 1 bottle | 71610-275-60 | Aphena Pharma Solutions - Tennessee | 8 May 2019 |
| 180 tablet in 1 bottle | 71610-275-80 | Aphena Pharma Solutions - Tennessee | 8 May 2019 |
| 270 tablet in 1 bottle | 71610-275-92 | Aphena Pharma Solutions - Tennessee | 8 May 2019 |
| 90 tablet in 1 bottle | 71610-550-60 | Aphena Pharma Solutions - Tennessee | 1 May 2021 |
| 180 tablet in 1 bottle | 71610-550-80 | Aphena Pharma Solutions - Tennessee | 1 May 2021 |
| 270 tablet in 1 bottle | 71610-550-92 | Aphena Pharma Solutions - Tennessee | 1 May 2021 |
| 100 tablet in 1 bottle | 66267-963-00 | NuCare Pharmaceuticals,Inc | 15 September 2017 |
| 12 tablet in 1 bottle | 68071-3053-0 | NuCare Pharmaceuticals,Inc | 16 March 2018 |
| 120 tablet in 1 bottle | 68071-3053-1 | NuCare Pharmaceuticals,Inc | 16 March 2018 |
| 20 tablet in 1 bottle | 68071-3053-2 | NuCare Pharmaceuticals,Inc | 16 March 2018 |
| 40 tablet in 1 bottle | 68071-3053-4 | NuCare Pharmaceuticals,Inc | 16 March 2018 |
| 60 tablet in 1 bottle | 68071-3053-6 | NuCare Pharmaceuticals,Inc | 16 March 2018 |
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.
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
Alternatives
Other makers and brands of Ibuprofen 800 mg tablet.
Other strengths and forms of Ibuprofen
Clinical summary
Ibuprofen is a nonsteroidal anti-inflammatory drug indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g,, among other approved uses. MedsAcross supplies Ibuprofen 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 IbuprofenFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ibuprofen Lysine prescribing information (Prasco Laboratories) · U.S. National Library of Medicine, DailyMed
- Pedea: European public assessment report (EPAR) · European Medicines Agency
- Vlustozik (previously Ibuprofen Gen.Orph): European public assessment report (EPAR) · European Medicines Agency
Need Ibu 800 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.