Medicine
Oxycodone 5 mg/5 mL oral solution
Oxycodone 5 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 14 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 controlled room temperature 20° to 25°C (68° to 77°F). Store…
Key facts
- Active ingredient (INN)
- Oxycodone
- Brand
- Sold under the generic name
- Strength
- 5 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle, 118 mL, 500 mL and 24 more
- Manufacturers
- Aurolife PharmaIndiaGenus LifesciencesPAI PharmaBryant Ranch PrepackMajor PharmaceuticalsAmerican Health PackagingAscent PharmaceuticalsQuagen PharmaceuticalsANI PharmaceuticalsEywa Pharma
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20° to 25°C (68° to 77°F). Store Oxycodone Hydrochloride Oral Solution securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- ATC code
- N02AA05 Oxycodone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 September 2013
- Identifiers
- RxCUI 1049604, 1049615DailyMed set ID 73b063b5-24b7-40bf-bc2a-c0e1bfaf61d1, e2e52a0e-a80b-4225-b034-37a62f839d92, e0079cc8-3642-47f0-9d14-28fd8f212c21 +14NDC 0121-4827, 63629-1174, 0121-0827 +15Application ANDA206914, ANDA207511, ANDA204979 +7
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 / 500 mL in 1 bottle | 13107-261-58 | Aurolife PharmaIndia | 27 January 2020 |
| 118 mL in 1 bottle | 0121-0827-04 | PAI Pharma | 8 April 2019 |
| 500 mL in 1 bottle | 0121-0827-16 | PAI Pharma | 8 April 2019 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0121-4827-40 | PAI Pharma | 10 April 2019 |
| 5 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0121-4827-50 | PAI Pharma | 10 January 2020 |
| 1 bottle in 1 carton / 473 mL in 1 bottle | 62559-151-16 | ANI Pharmaceuticals | 13 October 2015 |
| 30 mL in 1 bottle | 43602-190-31 | Ascent Pharmaceuticals | 13 July 2017 |
| 500 mL in 1 bottle | 43602-190-50 | Ascent Pharmaceuticals | 13 July 2017 |
| 1 bottle in 1 carton / 473 mL in 1 bottle | 71930-022-43 | Eywa Pharma | 1 March 2019 |
| 1 bottle, plastic in 1 carton / 100 mL in 1 bottle, plastic | 64950-354-10 | Genus Lifesciences | 9 September 2013 |
| 40 cup, unit-dose in 1 case / 5 mL in 1 cup, unit-dose | 64950-354-45 | Genus Lifesciences | 9 September 2013 |
| 1 bottle, plastic in 1 carton / 500 mL in 1 bottle, plastic | 64950-354-50 | Genus Lifesciences | 9 September 2013 |
| 50 cup, unit-dose in 1 case / 5 mL in 1 cup, unit-dose | 64950-354-55 | Genus Lifesciences | 9 September 2013 |
| 500 mL in 1 bottle | 0054-0390-63 | Hikma Pharmceuticals | 4 September 2014 |
| 1 bottle, plastic in 1 carton / 500 mL in 1 bottle, plastic | 10702-183-50 | KVK-Tech | 21 July 2017 |
| 1 bottle, plastic in 1 carton / 100 mL in 1 bottle, plastic | 70752-136-10 | Quagen Pharmaceuticals | 2 June 2021 |
| 1 bottle, plastic in 1 carton / 500 mL in 1 bottle, plastic | 70752-136-14 | Quagen Pharmaceuticals | 2 June 2021 |
| 1 bottle, plastic in 1 carton / 500 mL in 1 bottle, plastic | 0406-8556-05 | SpecGx | 30 April 2018 |
| 1 bottle in 1 carton / 473 mL in 1 bottle | 63629-1174-1 | Bryant Ranch Prepack | 1 March 2019 |
| 473 mL in 1 bottle | 63629-2104-1 | Bryant Ranch Prepack | 13 October 2015 |
| 1 bottle in 1 carton / 473 mL in 1 bottle | 72162-1749-2 | Bryant Ranch Prepack | 13 October 2015 |
| 1 bottle, plastic in 1 carton / 500 mL in 1 bottle, plastic | 0904-6678-40 | Major Pharmaceuticals | 23 November 2016 |
| 5 tray in 1 carton / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0904-6828-92 | Major Pharmaceuticals | 23 November 2016 |
| 4 tray in 1 carton / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0904-6828-94 | Major Pharmaceuticals | 23 November 2016 |
| 5 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 60687-406-67 | American Health Packaging | 22 April 2019 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 60687-406-77 | American Health Packaging | 22 April 2019 |
| 1 bottle, plastic in 1 carton / 60 mL in 1 bottle, plastic | 67296-2167-6 | Redpharm Drug | 9 September 2013 |
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 26 October 1998 | 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 Oxycodone
Clinical summary
Oxycodone is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is available as tablets, oral solution and extended-release tablets. MedsAcross supplies Oxycodone 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 OxycodoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Roxicodone prescribing information (SpecGx) · U.S. National Library of Medicine, DailyMed
Need Oxycodone 5 mg/5 mL oral solution 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.