Medicine
Ibuprofen 800 mg tablet
Ibuprofen 800 mg tablet is a generic prescription medicine for oral use, made by 47 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 room temperature. Avoid excessive heat 40°C (104°F).
Key facts
- Active ingredient (INN)
- Ibuprofen
- Brand
- Sold under the generic name
- Strength
- 800 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 454 more
- Manufacturers
- Ascend LaboratoriesIndiaGranules IndiaIndiaTime Cap LaboratoriesIndiaAurobindo PharmaIndiaMarksans PharmaIndiaStrides PharmaIndiaAmneal Pharmaceuticals of New York47 labelers on the register
- 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
- 20 November 2008
- Identifiers
- RxCUI 197807, 197805, 197806DailyMed set ID 31e6ac7a-fa3e-4dd4-e063-6294a90a29af, c1733fdb-5eed-2094-e053-2995a90a6c8e, 0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d8 +37NDC 71610-892, 71921-182, 72789-364 +37Application ANDA075682, ANDA071268, ANDA091625 +8
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 47 labelers. The register lists 457 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 67877-321-01 | Ascend LaboratoriesIndia | 21 December 2015 |
| 500 tablet, film coated in 1 bottle | 67877-321-05 | Ascend LaboratoriesIndia | 21 December 2015 |
| 30 tablet, film coated in 1 bottle | 67877-321-30 | Ascend LaboratoriesIndia | 21 December 2015 |
| 50 tablet, film coated in 1 bottle | 67877-321-50 | Ascend LaboratoriesIndia | 21 December 2015 |
| 100 tablet, film coated in 1 bottle | 67877-739-01 | Ascend LaboratoriesIndia | 15 September 2026 |
| 500 tablet, film coated in 1 bottle | 67877-739-05 | Ascend LaboratoriesIndia | 15 September 2026 |
| 30 tablet, film coated in 1 bottle | 67877-739-30 | Ascend LaboratoriesIndia | 15 September 2026 |
| 1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 67877-739-33 | Ascend LaboratoriesIndia | 15 September 2026 |
| 50 tablet, film coated in 1 bottle | 67877-739-50 | Ascend LaboratoriesIndia | 15 September 2026 |
| 60 tablet, film coated in 1 bottle | 67877-739-60 | Ascend LaboratoriesIndia | 15 September 2026 |
| 90 tablet, film coated in 1 bottle | 67877-739-90 | Ascend LaboratoriesIndia | 15 September 2026 |
| 50 tablet, film coated in 1 bottle | 62207-356-42 | Granules IndiaIndia | 21 September 2015 |
| 100 tablet, film coated in 1 bottle | 62207-356-43 | Granules IndiaIndia | 21 September 2015 |
| 500 tablet, film coated in 1 bottle | 62207-356-47 | Granules IndiaIndia | 21 September 2015 |
| 1000 tablet, film coated in 1 bottle | 62207-356-49 | Granules IndiaIndia | 21 September 2015 |
| 30 tablet, film coated in 1 bottle | 62207-356-54 | Granules IndiaIndia | 21 September 2015 |
| 100 tablet, film coated in 1 bottle | 70010-068-01 | Granules IndiaIndia | 18 February 2026 |
| 30 tablet, film coated in 1 bottle | 70010-068-03 | Granules IndiaIndia | 18 February 2026 |
| 500 tablet, film coated in 1 bottle | 70010-068-05 | Granules IndiaIndia | 18 February 2026 |
| 1000 tablet, film coated in 1 bottle | 70010-068-10 | Granules IndiaIndia | 18 February 2026 |
| 50 tablet, film coated in 1 bottle | 70010-068-50 | Granules IndiaIndia | 18 February 2026 |
| 9 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack | 70010-068-82 | Granules IndiaIndia | 18 February 2026 |
| 100 tablet in 1 bottle | 59651-362-01 | Aurobindo PharmaIndia | 8 May 2020 |
| 500 tablet in 1 bottle | 59651-362-05 | Aurobindo PharmaIndia | 8 May 2020 |
| 30 tablet in 1 bottle | 25000-123-03 | Marksans PharmaIndia | 28 February 2011 |
| 500 tablet in 1 bottle | 25000-123-12 | Marksans PharmaIndia | 28 February 2011 |
| 100 tablet, film coated in 1 bottle | 64380-807-06 | Strides PharmaIndia | 24 August 2018 |
| 500 tablet, film coated in 1 bottle | 64380-807-07 | Strides PharmaIndia | 24 August 2018 |
| 100 tablet, film coated in 1 bottle | 49483-604-01 | Time Cap LaboratoriesIndia | 30 December 2015 |
| 30 tablet, film coated in 1 bottle | 49483-604-03 | Time Cap LaboratoriesIndia | 30 December 2015 |
| 50 tablet, film coated in 1 bottle | 49483-604-05 | Time Cap LaboratoriesIndia | 30 December 2015 |
| 500 tablet, film coated in 1 bottle | 49483-604-50 | Time Cap LaboratoriesIndia | 30 December 2015 |
| 100 tablet in 1 bottle | 53746-137-01 | Amneal Pharmaceuticals of New York | 5 January 2009 |
| 500 tablet in 1 bottle | 53746-137-05 | Amneal Pharmaceuticals of New York | 5 January 2009 |
| 30 tablet in 1 bottle | 53746-137-30 | Amneal Pharmaceuticals of New York | 5 January 2009 |
| 50 tablet in 1 bottle | 53746-137-50 | Amneal Pharmaceuticals of New York | 5 January 2009 |
| 60 tablet in 1 bottle | 53746-137-60 | Amneal Pharmaceuticals of New York | 5 January 2009 |
| 90 tablet in 1 bottle | 53746-137-90 | Amneal Pharmaceuticals of New York | 5 January 2009 |
| 100 tablet in 1 bottle | 53746-466-01 | Amneal Pharmaceuticals of New York | 23 November 2009 |
| 500 tablet in 1 bottle | 53746-466-05 | Amneal Pharmaceuticals of New York | 23 November 2009 |
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
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