FDA — authorised 17 December 1984
- Application: ANDA088875
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Indication: SYRUP — ORAL
- Status: approved
🇺🇸 CODEINE PHOSPHATE in United States
FDA authorised CODEINE PHOSPHATE on 17 December 1984 · 24,919 US adverse-event reports
Marketing authorisations
FDA — authorised 22 December 1988
- Application: ANDA089647
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 31 January 2006
- Application: ANDA040650
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: PROMETHAZINE WITH CODEINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 7 December 2006
- Application: ANDA040660
- Marketing authorisation holder: GENUS LIFESCIENCES
- Local brand name: PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 26 March 2007
- Application: ANDA089990
- Marketing authorisation holder: STRIDES PHARMA INTL
- Indication: Labeling
- Status: approved
FDA — authorised 17 March 2010
- Application: ANDA090180
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 22 June 2011
- Application: ANDA089828
- Marketing authorisation holder: STRIDES PHARMA INTL
- Indication: Labeling
- Status: approved
FDA — authorised 24 April 2013
- Application: ANDA200894
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 29 August 2017
- Application: ANDA200386
- Marketing authorisation holder: COSETTE
- Indication: Labeling
- Status: approved
FDA — authorised 7 October 2019
- Application: ANDA089805
- Marketing authorisation holder: STRIDES PHARMA INTL
- Indication: Labeling
- Status: approved
FDA — authorised 8 October 2020
- Application: ANDA214238
- Marketing authorisation holder: QUAGEN
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 24,919
Most-reported reactions
- Dependence — 4,454 reports (17.87%)
- Pain — 2,838 reports (11.39%)
- Fatigue — 2,462 reports (9.88%)
- Nausea — 2,382 reports (9.56%)
- Drug Ineffective — 2,328 reports (9.34%)
- Arthralgia — 2,156 reports (8.65%)
- Dyspnoea — 2,113 reports (8.48%)
- Headache — 2,093 reports (8.4%)
- Diarrhoea — 2,061 reports (8.27%)
- Off Label Use — 2,032 reports (8.15%)
CODEINE PHOSPHATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is CODEINE PHOSPHATE approved in United States?
Yes. FDA authorised it on 17 December 1984; FDA authorised it on 22 December 1988; FDA authorised it on 31 January 2006.
Who is the marketing authorisation holder for CODEINE PHOSPHATE in United States?
PHARMOBEDIENT holds the US marketing authorisation.