Medicine
Ibuprofen 100 mg/5 mL oral suspension
Ibuprofen 100 mg/5 mL oral suspension is a generic prescription medicine for oral use, made by 9 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
Do not freeze. Store at 20 - 25ºC (68 - 77ºF).
Key facts
- Active ingredient (INN)
- Ibuprofen
- Brand
- Sold under the generic name
- Strength
- 100 mg/5 mL
- Dosage form
- Oral suspension
- Route
- Oral
- Packs
- 1 bottle, 473 mL and 12 more
- Manufacturers
- Aurobindo PharmaIndiaStrides PharmaIndiaSun Pharmaceutical IndustriesIndiaActavis PharmaPadagis Israel PharmaceuticalsProficient RxA-S Medication SolutionsNuCare Pharmaceuticals,IncRemedyrepack
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 20 - 25ºC (68 - 77ºF).
- 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
- 8 December 2004
- Identifiers
- RxCUI 197803DailyMed set ID 9e9fb921-6b6a-422e-95b6-41d6b9047b80, 72b32512-05c7-4113-b0cc-de9c97de2abb, 38ebacc3-378f-483e-babc-76119677e7df +7NDC 71205-716, 71205-367, 64380-997 +7Application ANDA076925, ANDA074978, ANDA215311 +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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 120 mL in 1 bottle | 59651-032-12 | Aurobindo PharmaIndia | 16 February 2018 |
| 1 bottle in 1 carton / 473 mL in 1 bottle | 59651-032-47 | Aurobindo PharmaIndia | 18 May 2018 |
| 1 bottle in 1 carton / 118 mL in 1 bottle | 64380-997-03 | Strides PharmaIndia | 19 September 2023 |
| 473 mL in 1 bottle | 64380-997-04 | Strides PharmaIndia | 19 September 2023 |
| 1 bottle in 1 carton / 118 mL in 1 bottle | 51672-1385-8 | Sun Pharmaceutical IndustriesIndia | 23 June 2017 |
| 473 mL in 1 bottle | 51672-1385-9 | Sun Pharmaceutical IndustriesIndia | 23 June 2017 |
| 473 mL in 1 bottle | 0472-2002-16 | Actavis Pharma | 16 July 2018 |
| 1 bottle in 1 carton / 118 mL in 1 bottle | 0472-2002-94 | Actavis Pharma | 14 August 2018 |
| 1 bottle in 1 carton / 120 mL in 1 bottle | 45802-952-26 | Padagis Israel Pharmaceuticals | 28 December 2004 |
| 473 mL in 1 bottle | 45802-952-43 | Padagis Israel Pharmaceuticals | 8 December 2004 |
| 1 bottle in 1 carton / 118 mL in 1 bottle | 71205-367-72 | Proficient Rx | 22 November 2019 |
| 1 bottle in 1 carton / 120 mL in 1 bottle | 71205-716-72 | Proficient Rx | 14 November 2022 |
| 1 bottle in 1 carton / 118 mL in 1 bottle | 50090-8175-0 | A-S Medication Solutions | 2 November 2026 |
| 1 bottle in 1 carton / 120 mL in 1 bottle | 68071-3589-4 | NuCare Pharmaceuticals,Inc | 20 March 2024 |
| 1 bottle in 1 carton / 118 mL in 1 bottle | 70518-4595-0 | Remedyrepack | 24 March 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.
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 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 Ibuprofen 100 mg/5 mL oral suspension 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.