Medicine
Combogesic 325 mg/97.5 mg tablet
Combogesic 325 mg/97.5 mg tablet is a prescription medicine containing Acetaminophen and Ibuprofen for oral use, marketed by AFT Pharmaceuticals, 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 20°C to 25°C (68°F to 77°F) with excursions permitted within USP…
Key facts
- Active ingredient (INN)
- Acetaminophen and Ibuprofen
- Brand
- Combogesic
- Strength
- 325 mg/97.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 250 tablets, 60 tablets, 120 tablets and 2 more
- Marketing authorisation holder
- AFT Pharmaceuticals
- Manufacturers
- AFT PharmaceuticalsPreferred PharmaceuticalsHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F) with excursions permitted within USP controlled room temperature of 15°C to 30°C (59°F to 86°F). Protect from moisture and light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 January 2025
- Identifiers
- RxCUI 2675760, 2675765DailyMed set ID f863558f-2a44-41f8-a6b7-271851d4c2ff, b32651c4-7fa0-415b-91eb-854aa1c28f2a, cd03b658-dba1-4a12-8f6f-ab00da499c05 +1NDC 72260-129, 0143-9432, 68788-4009 +1Application NDA209471
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 |
|---|---|---|---|
| 250 tablet, film coated in 1 bottle, plastic | 72260-129-01 | AFT Pharmaceuticals | 30 June 2026 |
| 60 tablet, film coated in 1 bottle, plastic | 72260-129-02 | AFT Pharmaceuticals | 30 June 2026 |
| 250 tablet, film coated in 1 bottle, plastic | 0143-9432-27 | Hikma Pharmaceuticals | 6 January 2025 |
| 120 tablet, film coated in 1 bottle, plastic | 68788-4009-1 | Preferred Pharmaceuticals | 4 September 2025 |
| 120 tablet, film coated in 1 bottle, plastic | 68788-4181-1 | Preferred Pharmaceuticals | 20 August 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 |
| US FDA | First approved 28 February 2020 | Drugs@FDA |
| 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
Other strengths and forms of Acetaminophen and Ibuprofen
Clinical summary
Acetaminophen and Ibuprofen is a fixed-dose combination medicine indicated in adults for the short-term management of mild to moderate acute pain. It is available as tablets and injection for oral and intravenous use. MedsAcross supplies Acetaminophen and 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 Acetaminophen and 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
- Combogesic prescribing information (AFT Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Combogesic 325 mg/97.5 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.