Medicine
Codeine, Phenylephrine and Promethazine 10 mg/5 mg/6.25 mg per 5 mL syrup
Codeine, Phenylephrine and Promethazine 10 mg/5 mg/6.25 mg per 5 mL syrup 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 20° to 25° C (68° to 77° F). Protect from light.
Key facts
- Active ingredient (INN)
- Codeine, Phenylephrine and Promethazine
- Brand
- Sold under the generic name
- Strength
- 10 mg/5 mg/6.25 mg per 5 mL
- Dosage form
- Syrup
- Route
- Oral
- Packs
- 118 mL, 473 mL
- Manufacturer
- Amneal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25° C (68° to 77° F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CV
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 November 2013
- Identifiers
- RxCUI 996757DailyMed set ID 5f23b254-872b-4e88-91be-710c3ea7687bNDC 65162-694Application ANDA200963
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 |
|---|---|---|---|
| 118 mL in 1 bottle | 65162-694-86 | Amneal Pharmaceuticals | 1 November 2013 |
| 473 mL in 1 bottle | 65162-694-90 | Amneal Pharmaceuticals | 1 November 2013 |
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 21 January 1952 | 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
Clinical summary
Codeine, Phenylephrine and Promethazine is a fixed-dose combination of an opioid agonist, a phenothiazine and an alpha-1 adrenergic agonist indicated for the temporary relief of coughs and upper respiratory symptoms, among other approved uses. MedsAcross supplies Codeine, Phenylephrine and Promethazine 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 Codeine, Phenylephrine and PromethazineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Promethazine and Phenylephrine HCl, and Codeine Phosphate prescribing information (Amneal Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Codeine, Phenylephrine and Promethazine 10 mg/5 mg/6.25 mg per 5 mL syrup 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.