Medicine
Hydrocodone and Ibuprofen 5 mg/200 mg tablet
Hydrocodone and Ibuprofen 5 mg/200 mg tablet is a generic prescription medicine for oral use, 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 room temperature 20° to 25°C (68° to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Hydrocodone and Ibuprofen
- Brand
- Sold under the generic name
- Strength
- 5 mg/200 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets
- Manufacturer
- Amneal Pharmaceuticals of New York
- Origin register
- US FDA, United States
- Storage
- Store at room temperature 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). Store hydrocodone bitartrate and ibuprofen 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
- 18 February 2010
- Identifiers
- RxCUI 858770, 858778, 858798 +1DailyMed set ID abc33718-4e88-43ea-9ffa-2b04ffc812efNDC 53746-146Application ANDA076642
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 53746-146-01 | Amneal Pharmaceuticals of New York | 18 February 2010 |
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 23 September 1997 | 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 Hydrocodone and Ibuprofen
Clinical summary
Hydrocodone and Ibuprofen is a fixed-dose combination of a nonsteroidal anti-inflammatory drug and an opioid agonist. It is available as tablets for oral use. MedsAcross supplies Hydrocodone 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 Hydrocodone 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
- Hydrocodone Bitartrate and Ibuprofen prescribing information (Aurolife Pharma) · U.S. National Library of Medicine, DailyMed
Need Hydrocodone and Ibuprofen 5 mg/200 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.