Medicine
Codeine and Promethazine 10 mg/6.25 mg per 5 mL oral solution
Codeine and Promethazine 10 mg/6.25 mg per 5 mL oral solution is a generic prescription medicine for oral use, made by 5 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 from 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Codeine and Promethazine
- Brand
- Sold under the generic name
- Strength
- 10 mg/6.25 mg per 5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 473 mL, 118 mL, 72 cup and 4 more
- Manufacturers
- Atlantic BiologicalsQuagen PharmaceuticalsBryant Ranch PrepackCosette PharmaceuticalsCranbury Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted from 15° to 30°C (59° to 86°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
- 12 March 2018
- Identifiers
- RxCUI 991486DailyMed set ID 785c605e-1907-4fac-8b69-d504a2076f8e, 3b02cda4-9b24-79c9-e063-6294a90af5b9, f8fb13e3-bc09-4004-a911-a38b6bbb0058 +2NDC 27808-065, 0713-0823, 17856-0065 +2Application ANDA200386, ANDA214238
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 |
|---|---|---|---|
| 473 mL in 1 bottle, plastic | 0713-0823-75 | Cosette Pharmaceuticals | 19 December 2025 |
| 473 mL in 1 bottle, plastic | 27808-065-02 | Cranbury Pharmaceuticals | 12 March 2018 |
| 118 mL in 1 bottle, plastic | 70752-139-06 | Quagen Pharmaceuticals | 8 October 2020 |
| 473 mL in 1 bottle, plastic | 70752-139-12 | Quagen Pharmaceuticals | 8 October 2020 |
| 72 cup, unit-dose in 1 box, unit-dose / 5 mL in 1 cup, unit-dose | 17856-0065-1 | Atlantic Biologicals | 7 August 2020 |
| 1 cup, unit-dose in 1 bag / 5 mL in 1 cup, unit-dose | 17856-0065-2 | Atlantic Biologicals | 4 June 2025 |
| 473 mL in 1 bottle, plastic | 72162-2042-2 | Bryant Ranch Prepack | 12 March 2018 |
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 and Promethazine is a fixed-dose combination of an opioid agonist and a phenothiazine. It is available as oral solution. MedsAcross supplies Codeine 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 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 Hydrochloride and Codeine Phosphate prescribing information (Cosette Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Codeine and Promethazine 10 mg/6.25 mg per 5 mL oral solution 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.