Medicine
Promethazine 6.25 mg/5 mL oral solution
Promethazine 6.25 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 6 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 20º to 25ºC (68º to 77ºF). Protect from light.
Key facts
- Active ingredient (INN)
- Promethazine
- Brand
- Sold under the generic name
- Strength
- 6.25 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 2 trays, 120 mL, 473 mL and 9 more
- Manufacturers
- Chartwell RXBryant Ranch PrepackChartwell Governmental & Specialty RXQuagen PharmaceuticalsKesin PharmaPAI Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 September 1998
- Identifiers
- RxCUI 992432DailyMed set ID 28793bd2-bd40-4571-e063-6394a90ae789, 7a186bcd-ab8c-4695-8289-4cd33bb551cf, e5d2156d-1f66-4fdf-a3ae-5e1325218c8b +4NDC 81033-016, 0121-1854, 68999-774 +4Application ANDA040891, ANDA040643, ANDA040026 +1
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 |
|---|---|---|---|
| 2 tray in 1 box / 10 cup in 1 tray / 10 mL in 1 cup | 68999-774-23 | Chartwell Governmental & Specialty RX | 20 November 2025 |
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 68999-774-24 | Chartwell Governmental & Specialty RX | 20 November 2025 |
| 2 tray in 1 box / 10 cup in 1 tray / 10 mL in 1 cup | 62135-774-23 | Chartwell RX | 10 February 2025 |
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 62135-774-24 | Chartwell RX | 10 February 2025 |
| 120 mL in 1 bottle | 62135-774-41 | Chartwell RX | 27 November 2023 |
| 473 mL in 1 bottle | 62135-774-47 | Chartwell RX | 27 November 2023 |
| 473 mL in 1 bottle | 0121-1854-16 | PAI Pharma | 7 August 2025 |
| 118 mL in 1 bottle, plastic | 70752-138-06 | Quagen Pharmaceuticals | 12 July 2021 |
| 473 mL in 1 bottle, plastic | 70752-138-12 | Quagen Pharmaceuticals | 12 July 2021 |
| 473 mL in 1 bottle | 72162-2071-2 | Bryant Ranch Prepack | 15 August 2023 |
| 473 mL in 1 bottle | 72162-2377-2 | Bryant Ranch Prepack | 30 July 2024 |
| 50 cup, unit-dose in 1 carton / 5 mL in 1 cup, unit-dose | 81033-016-50 | Kesin Pharma | 31 December 2024 |
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 29 March 1951 | 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 Promethazine
Clinical summary
Promethazine is a phenothiazine. It is available as tablets, injection and suppositories for oral, intramuscular and intravenous use. MedsAcross supplies 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 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 prescribing information (KVK-Tech) · U.S. National Library of Medicine, DailyMed
Need Promethazine 6.25 mg/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.