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Medicine

Hydrocodone 15 mg extended-release capsule

Hydrocodone · Oral
Available on requestPrescription onlyUS FDAControlled, schedule CIIGeneric name

Hydrocodone 15 mg extended-release capsule 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

Available on request

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 to 15° to 30°C (59° to 86°F).

Key facts

Active ingredient (INN)
Hydrocodone
Brand
Sold under the generic name
Strength
15 mg
Dosage form
Extended-release capsule
Route
Oral
Packs
60 capsules
Manufacturer
Alvogen
Origin register
US FDA, United States
Storage
Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
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
21 January 2020
Identifiers
RxCUI 1860491, 1860493, 1860495 +3DailyMed set ID a7b8ea07-e926-f0a5-c20d-92f23ed350d0NDC 47781-410Application ANDA206986

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

PackCodeLabelerMarketed since
60 capsule, extended release in 1 bottle47781-410-60Alvogen21 January 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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 25 October 2013Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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

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 Hydrocodone

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Hydrocodone 15 mg extended-release capsule 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.