Medicine
Caldolor 800 mg/8 mL injection
Caldolor 800 mg/8 mL injection is a prescription medicine containing Ibuprofen for intravenous use, marketed by Cumberland 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 controlled room temperature 20 °C to 25 °C (68 °F to 77 °F)…
Key facts
- Active ingredient (INN)
- Ibuprofen
- Brand
- Caldolor
- Strength
- 800 mg/8 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 25 vials of 8 mL
- Marketing authorisation holder
- Cumberland Pharmaceuticals
- Manufacturer
- Cumberland Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20 °C to 25 °C (68 °F to 77 °F), excursions permitted between 15 °C to 30 °C (59 °F to 86 °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
- 11 June 2009
- Identifiers
- RxCUI 854183, 854187, 2178273 +1DailyMed set ID 1eaa7790-f1a1-4f51-b10a-cbbaf033f684NDC 66220-287Application NDA022348
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 |
|---|---|---|---|
| 25 vial in 1 carton / 8 mL in 1 vial | 66220-287-08 | Cumberland Pharmaceuticals | 11 June 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
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 Caldolor 800 mg/8 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.