Medicine
Desloratadine 5 mg tablet
Desloratadine 5 mg tablet is a generic prescription medicine for oral use, made by 7 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). Avoid exposure at or above 30ºC (86ºF)…
Key facts
- Active ingredient (INN)
- Desloratadine
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 90 tablets and 17 more
- Manufacturers
- LupinIndiaNatco PharmaIndiaBryant Ranch PrepackA-S Medication SolutionsBionpharmaMorepen BioVirtus Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Avoid exposure at or above 30ºC (86ºF). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R06AX27 Desloratadine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 February 2013
- Identifiers
- RxCUI 349420DailyMed set ID e4db30a5-48e5-4fe3-8793-30b6866f87c1, 0fe374d0-c14b-4102-b568-eb79165fc7ef, 69b9635b-c790-4316-a790-67b0f5512b72 +7NDC 69339-194, 69543-107, 50090-4794 +7Application ANDA078351, ANDA078355, ANDA078352 +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 |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 68180-153-01 | LupinIndia | 25 February 2013 |
| 500 tablet, film coated in 1 bottle | 68180-153-02 | LupinIndia | 25 February 2013 |
| 100 tablet, film coated in 1 bottle | 69339-194-01 | Natco PharmaIndia | 1 April 2026 |
| 500 tablet, film coated in 1 bottle | 69339-194-05 | Natco PharmaIndia | 1 April 2026 |
| 100 tablet, film coated in 1 bottle, plastic | 69452-363-20 | Bionpharma | 28 November 2023 |
| 500 tablet, film coated in 1 bottle, plastic | 69452-363-30 | Bionpharma | 28 November 2023 |
| 100 tablet in 1 bottle | 87717-001-01 | Morepen Bio | 27 August 2026 |
| 500 tablet in 1 bottle | 87717-001-02 | Morepen Bio | 27 August 2026 |
| 100 tablet in 1 bottle, plastic | 69543-107-10 | Virtus Pharmaceuticals | 12 June 2015 |
| 500 tablet in 1 bottle, plastic | 69543-107-50 | Virtus Pharmaceuticals | 12 June 2015 |
| 90 tablet in 1 bottle | 50090-3975-0 | A-S Medication Solutions | 13 December 2018 |
| 30 tablet in 1 bottle | 50090-3975-1 | A-S Medication Solutions | 6 December 2018 |
| 90 tablet, film coated in 1 bottle | 50090-4794-0 | A-S Medication Solutions | 12 December 2019 |
| 90 tablet, film coated in 1 bottle | 50090-6724-0 | A-S Medication Solutions | 5 October 2023 |
| 30 tablet, film coated in 1 bottle | 71335-1000-1 | Bryant Ranch Prepack | 13 November 2018 |
| 90 tablet, film coated in 1 bottle | 71335-1000-2 | Bryant Ranch Prepack | 9 April 2024 |
| 60 tablet, film coated in 1 bottle | 71335-1000-3 | Bryant Ranch Prepack | 9 April 2024 |
| 100 tablet in 1 bottle, plastic | 72162-2308-1 | Bryant Ranch Prepack | 7 May 2024 |
| 30 tablet in 1 bottle, plastic | 72162-2308-3 | Bryant Ranch Prepack | 7 May 2024 |
| 500 tablet in 1 bottle, plastic | 72162-2308-5 | Bryant Ranch Prepack | 7 May 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.
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 Desloratadine 5 mg tablet.
Other strengths and forms of Desloratadine
Clinical summary
Desloratadine is a histamine-1 receptor antagonist indicated for seasonal Allergic Rhinitis, among other approved uses. It is available as tablets, orally disintegrating tablets and oral solution. MedsAcross supplies Desloratadine 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 DesloratadineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Clarinex prescribing information (Organon) · U.S. National Library of Medicine, DailyMed
- Aerius: European public assessment report (EPAR) · European Medicines Agency
- Azomyr: European public assessment report (EPAR) · European Medicines Agency
Need Desloratadine 5 mg tablet for your hospital or patient?
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