Medicine
Combogesic IV 1000 mg/300 mg per 100 mL injection
Combogesic IV 1000 mg/300 mg per 100 mL injection is a prescription medicine containing Acetaminophen and Ibuprofen for intravenous use, marketed by Hikma 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
Do not refrigerate or freeze. Store at 20°C to 25°C (68°F to 77°F). Excursions…
Key facts
- Active ingredient (INN)
- Acetaminophen and Ibuprofen
- Brand
- Combogesic IV
- Strength
- 1000 mg/300 mg per 100 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 100 mL
- Marketing authorisation holder
- Hikma Pharmaceuticals
- Manufacturer
- Hikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not refrigerate or freeze. Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F). Store in the original carton in order to protect from light. Protect from heat.
- 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
- 5 February 2024
- Identifiers
- RxCUI 2673874, 2673880DailyMed set ID be408a5a-48e4-43c0-9cb1-bbf830b54f5bNDC 0143-9150Application NDA215320
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 |
|---|---|---|---|
| 10 vial in 1 carton / 100 mL in 1 vial | 0143-9150-10 | Hikma Pharmaceuticals | 5 February 2024 |
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 IV 1000 mg/300 mg per 100 mL injection 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.