Medicine
Codeine 15 mg tablet
Codeine 15 mg tablet is a generic prescription medicine for oral use, made by 2 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 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Codeine
- Brand
- Sold under the generic name
- Strength
- 15 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 10 blister pack, 4 blister pack
- Manufacturers
- Hikma PharmaceuticalsLannett
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). Protect from moisture. Store codeine sulfate tablets securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- ATC code
- R05DA04 Codeine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 July 2009
- Identifiers
- RxCUI 997170, 997287, 997296DailyMed set ID 5819bdf7-300e-45b8-8f3a-447b53656293, 010905f9-3bcb-4b50-9fe8-a3ad0010f14cNDC 0527-1727, 0054-0243Application ANDA203046, NDA022402
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 |
|---|---|---|---|
| 10 blister pack in 1 box / 10 tablet in 1 blister pack | 0054-0243-24 | Hikma Pharmaceuticals | 16 July 2009 |
| 4 blister pack in 1 carton / 25 tablet in 1 blister pack | 0527-1727-91 | Lannett | 13 June 2014 |
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 16 July 2009 | 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 Codeine
Clinical summary
Codeine is an opioid agonist indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. It is available as tablets for oral use. MedsAcross supplies Codeine 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 CodeineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Codeine sulfate prescribing information (Hikma Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Codeine 15 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.