Medicine
Karbinal ER 4 mg/5 mL extended-release oral suspension
Karbinal ER 4 mg/5 mL extended-release oral suspension is a prescription medicine containing Carbinoxamine for oral use, marketed by Aytu Therapeutics, 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 25ºC (77ºF), excursions permitted from 15ºC to 30ºC (59ºF to 86ºF).
Key facts
- Active ingredient (INN)
- Carbinoxamine
- Brand
- Karbinal ER
- Strength
- 4 mg/5 mL
- Dosage form
- Extended-release oral suspension
- Route
- Oral
- Packs
- 480 mL
- Marketing authorisation holder
- Aytu Therapeutics
- Manufacturer
- Aytu Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at 25ºC (77ºF), excursions permitted from 15ºC to 30ºC (59ºF to 86ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R06AA08 Carbinoxamine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 January 2014
- Identifiers
- RxCUI 1374770, 1374776DailyMed set ID c40b3f4e-2d71-41a1-a1fc-f64f38724879NDC 23594-101Application NDA022556
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 |
|---|---|---|---|
| 480 mL in 1 bottle, plastic | 23594-101-05 | Aytu Therapeutics | 3 January 2014 |
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 28 March 2013 | 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
Alternatives
Other makers and brands of Carbinoxamine 4 mg/5 mL extended-release oral suspension.
Other strengths and forms of Carbinoxamine
Clinical summary
Carbinoxamine is a histamine-1 receptor antagonist. It is available as tablets, extended-release oral suspension and oral solution. MedsAcross supplies Carbinoxamine 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 CarbinoxamineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Carbinoxamine Maleate Extended-Release Oral Suspension prescribing information (Neos Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Karbinal ER 4 mg/5 mL extended-release oral suspension 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.