Medicine
Hydrocodone 40 mg extended-release tablet
Hydrocodone 40 mg extended-release 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 25°C (77°F), excursions permitted between 15°C to 30°C (59°F to…
Key facts
- Active ingredient (INN)
- Hydrocodone
- Brand
- Sold under the generic name
- Strength
- 40 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 60 tablets
- Manufacturer
- Alvogen
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Store Hydrocodone Bitartrate Extended-Release Tablets securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- ATC code
- R05DA03 Hydrocodone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 March 2021
- Identifiers
- RxCUI 1595730, 1595740, 1595746 +4DailyMed set ID f7b55d14-0980-b680-8ceb-7489ff65455eNDC 47781-394Application ANDA208269
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 |
|---|---|---|---|
| 60 tablet, extended release in 1 bottle | 47781-394-60 | Alvogen | 3 March 2021 |
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 25 October 2013 | 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 Hydrocodone 40 mg extended-release tablet.
Other strengths and forms of Hydrocodone
Clinical summary
Hydrocodone is an opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids, among other approved uses. MedsAcross supplies Hydrocodone 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 HydrocodoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Hysingla ER prescribing information (Knoa Pharma) · U.S. National Library of Medicine, DailyMed
Need Hydrocodone 40 mg extended-release 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.