Medicine
Prolate 300 mg/10 mg tablet
Prolate 300 mg/10 mg tablet is a prescription medicine containing Acetaminophen and Oxycodone for oral use, marketed by Forte Bio-Pharma, 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° to 25°C (68° to 77°F). Protect from moisture. Store oxycodone and…
Key facts
- Active ingredient (INN)
- Acetaminophen and Oxycodone
- Brand
- Prolate
- Strength
- 300 mg/10 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets
- Marketing authorisation holder
- Forte Bio-Pharma
- Manufacturer
- Forte Bio-Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from moisture. Store oxycodone and acetaminophen tablets securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 February 2020
- Identifiers
- RxCUI 1014599, 1014615, 1014632 +3DailyMed set ID 9cbbfa94-37b9-9652-e053-2995a90a736bNDC 72245-683Application ANDA040608
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 |
|---|---|---|---|
| 30 tablet in 1 bottle, plastic | 72245-683-03 | Forte Bio-Pharma | 17 February 2020 |
| 100 tablet in 1 bottle, plastic | 72245-683-10 | Forte Bio-Pharma | 17 February 2020 |
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 11 March 2014 | 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
Alternatives
Other makers and brands of Acetaminophen and Oxycodone 300 mg/10 mg tablet.
Other strengths and forms of Acetaminophen and Oxycodone
Clinical summary
Acetaminophen and Oxycodone is a fixed-dose combination medicine indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. MedsAcross supplies Acetaminophen and 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 Acetaminophen and 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
- Oxycodone and Acetaminophen prescribing information (Granules India) · U.S. National Library of Medicine, DailyMed
Need Prolate 300 mg/10 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.