Medicine
Clemastine 0.67 mg/5 mL syrup
Clemastine 0.67 mg/5 mL syrup is a generic prescription medicine for oral use, made by 2 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 controlled room temperature, between 20° and 25°C (68° and 77°F).
Key facts
- Active ingredient (INN)
- Clemastine
- Brand
- Sold under the generic name
- Strength
- 0.67 mg/5 mL
- Dosage form
- Syrup
- Route
- Oral
- Packs
- 120 mL
- Manufacturers
- Chartwell RXGenus Lifesciences
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature, between 20° and 25°C (68° and 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D04AA14 Clemastine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 December 1997
- Identifiers
- RxCUI 857430DailyMed set ID 5c99e7af-86a5-4c17-82d5-2d4119e4fe72, 6663f1b0-5353-401f-b9d3-d9f69ad08fbfNDC 64950-324, 62135-713Application ANDA073399, ANDA074884
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 |
|---|---|---|---|
| 120 mL in 1 bottle | 62135-713-41 | Chartwell RX | 7 July 2023 |
| 120 mL in 1 bottle | 64950-324-12 | Genus Lifesciences | 22 November 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 25 February 1977 | 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 Clemastine
Clinical summary
Clemastine is a prescription medicine indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation, among other approved uses. It is available as syrup and tablets for oral use. MedsAcross supplies Clemastine 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 ClemastineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CLEMSZA prescribing information (IPG Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Clemastine 0.67 mg/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.