Medicine
Brompheniramine, Dextromethorphan and Pseudoephedrine 2 mg/10 mg/30 mg per 5 mL syrup
Brompheniramine, Dextromethorphan and Pseudoephedrine 2 mg/10 mg/30 mg per 5 mL syrup is a generic prescription medicine for oral use, made by 13 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).
Key facts
- Active ingredient (INN)
- Brompheniramine, Dextromethorphan and Pseudoephedrine
- Brand
- Sold under the generic name
- Strength
- 2 mg/10 mg/30 mg per 5 mL
- Dosage form
- Syrup
- Route
- Oral
- Packs
- 473 mL, 118 mL, 2 trays and 27 more
- Manufacturers
- Ascend LaboratoriesIndiaDr. Reddy's LaboratoriesIndiaAcella PharmaceuticalsBryant Ranch PrepackChartwell RXProficient RxRemedyrepackBionpharmaPadagisSportpharm
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- 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
- 6 February 2015
- Identifiers
- RxCUI 1357010DailyMed set ID 06db369d-09fe-4ca2-b98c-705356b7c403, 1045e307-f60d-482d-8e06-40e72b84c651, 036b587a-7bfe-4149-bd05-34a37e3e84b6 +14NDC 0574-1104, 42192-607, 67877-558 +14Application ANDA205292, ANDA203375, ANDA210647 +4
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 | 67877-558-16 | Ascend LaboratoriesIndia | 5 January 2026 |
| 118 mL in 1 bottle | 67877-558-17 | Ascend LaboratoriesIndia | 5 January 2026 |
| 118 mL in 1 bottle, plastic | 75907-207-04 | Dr. Reddy's LaboratoriesIndia | 30 September 2024 |
| 473 mL in 1 bottle, plastic | 75907-207-16 | Dr. Reddy's LaboratoriesIndia | 30 September 2024 |
| 118 mL in 1 bottle, plastic | 42192-607-04 | Acella Pharmaceuticals | 21 September 2016 |
| 473 mL in 1 bottle, plastic | 42192-607-16 | Acella Pharmaceuticals | 21 September 2016 |
| 118 mL in 1 bottle, plastic | 42192-630-04 | Acella Pharmaceuticals | 1 February 2025 |
| 473 mL in 1 bottle, plastic | 42192-630-16 | Acella Pharmaceuticals | 1 February 2025 |
| 118 mL in 1 bottle | 69452-478-55 | Bionpharma | 1 October 2025 |
| 473 mL in 1 bottle | 69452-478-88 | Bionpharma | 1 October 2025 |
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 68999-302-24 | Chartwell Governmental & Specialty RX | 30 October 2025 |
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 62135-302-24 | Chartwell RX | 16 October 2024 |
| 473 mL in 1 bottle | 62135-302-47 | Chartwell RX | 23 January 2023 |
| 118 mL in 1 bottle | 62135-302-48 | Chartwell RX | 23 January 2023 |
| 473 mL in 1 bottle | 71930-026-43 | Eywa Pharma | 26 June 2020 |
| 118 mL in 1 bottle, plastic | 0574-1104-04 | Padagis | 6 February 2015 |
| 473 mL in 1 bottle, plastic | 0574-1104-16 | Padagis | 6 February 2015 |
| 118 mL in 1 bottle, plastic | 63629-8615-1 | Bryant Ranch Prepack | 6 February 2015 |
| 473 mL in 1 bottle, plastic | 63629-8616-1 | Bryant Ranch Prepack | 6 February 2015 |
| 118 mL in 1 bottle, plastic | 72162-1123-2 | Bryant Ranch Prepack | 16 August 2023 |
| 473 mL in 1 bottle, plastic | 72162-1123-4 | Bryant Ranch Prepack | 16 August 2023 |
| 118 mL in 1 bottle, plastic | 63187-664-04 | Proficient Rx | 1 December 2018 |
| 118 mL in 1 bottle, plastic | 63187-930-04 | Proficient Rx | 1 November 2017 |
| 473 mL in 1 bottle, plastic | 63187-930-16 | Proficient Rx | 1 November 2017 |
| 118 mL in 1 bottle, plastic | 50090-5625-0 | A-S Medication Solutions | 31 August 2021 |
| 3 cup in 1 box / 20 mL in 1 cup | 70518-4526-0 | Remedyrepack | 1 December 2025 |
| 6 cup in 1 box / 10 mL in 1 cup | 70518-4526-2 | Remedyrepack | 10 December 2025 |
| 12 cup in 1 box / 5 mL in 1 cup | 70518-4526-4 | Remedyrepack | 12 January 2026 |
| 118 mL in 1 bottle, plastic | 85766-250-04 | Sportpharm | 24 July 2026 |
| 473 mL in 1 bottle, plastic | 85766-250-16 | Sportpharm | 24 July 2026 |
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 24 August 1984 | 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 Brompheniramine, Dextromethorphan and Pseudoephedrine
Clinical summary
Brompheniramine, Dextromethorphan and Pseudoephedrine is a fixed-dose combination of a sigma-1 agonist, an uncompetitive N-methyl-D-aspartate receptor antagonist and an alpha-adrenergic agonist. It is available as syrup and oral solution. MedsAcross supplies Brompheniramine, Dextromethorphan and Pseudoephedrine 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 Brompheniramine, Dextromethorphan and PseudoephedrineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide prescribing information (Dr. Reddy's Laboratories) · U.S. National Library of Medicine, DailyMed
Need Brompheniramine, Dextromethorphan and Pseudoephedrine 2 mg/10 mg/30 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.