Medicine
Darifenacin 7.5 mg extended-release tablet
Darifenacin 7.5 mg extended-release 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 25° C (77° F), excursions permitted to 15 to 30° C (59 to 86° F)…
Key facts
- Active ingredient (INN)
- Darifenacin
- Brand
- Sold under the generic name
- Strength
- 7.5 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 8 tablets, 30 tablets, 90 tablets and 21 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaCiplaIndiaMacleods PharmaceuticalsIndiaTorrent PharmaceuticalsIndiaRising Pharma HoldingsBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Store at 25° C (77° F), excursions permitted to 15 to 30° C (59 to 86° F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G04BD10 Darifenacin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 September 2016
- Identifiers
- RxCUI 485421, 485423DailyMed set ID da7c2732-232c-4e71-92d9-577ef8617f56, e2aa9544-0136-463d-a73b-1a299534446a, 9f6952c8-e547-4f3e-a978-a88d6ea9dc10 +5NDC 46708-223, 16571-767, 62332-223 +5Application ANDA207681, ANDA206743, ANDA205209 +2
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 |
|---|---|---|---|
| 8 tablet, extended release in 1 blister pack | 46708-223-08 | Alembic PharmaceuticalsIndia | 12 December 2017 |
| 30 tablet, extended release in 1 bottle | 46708-223-30 | Alembic PharmaceuticalsIndia | 12 December 2017 |
| 90 tablet, extended release in 1 bottle | 46708-223-90 | Alembic PharmaceuticalsIndia | 12 December 2017 |
| 1000 tablet, extended release in 1 bottle | 46708-223-91 | Alembic PharmaceuticalsIndia | 12 December 2017 |
| 8 tablet, extended release in 1 blister pack | 62332-223-08 | Alembic PharmaceuticalsIndia | 12 December 2017 |
| 30 tablet, extended release in 1 bottle | 62332-223-30 | Alembic PharmaceuticalsIndia | 12 December 2017 |
| 90 tablet, extended release in 1 bottle | 62332-223-90 | Alembic PharmaceuticalsIndia | 12 December 2017 |
| 1000 tablet, extended release in 1 bottle | 62332-223-91 | Alembic PharmaceuticalsIndia | 12 December 2017 |
| 500 tablet, film coated, extended release in 1 bottle | 65862-861-05 | Aurobindo PharmaIndia | 19 September 2016 |
| 30 tablet, film coated, extended release in 1 bottle | 65862-861-30 | Aurobindo PharmaIndia | 19 September 2016 |
| 90 tablet, film coated, extended release in 1 bottle | 65862-861-90 | Aurobindo PharmaIndia | 19 September 2016 |
| 1000 tablet, film coated, extended release in 1 bottle | 65862-861-99 | Aurobindo PharmaIndia | 19 September 2016 |
| 30 tablet, extended release in 1 bottle | 69097-431-02 | CiplaIndia | 1 September 2016 |
| 90 tablet, extended release in 1 bottle | 69097-431-05 | CiplaIndia | 1 September 2016 |
| 1000 tablet, extended release in 1 bottle | 69097-431-15 | CiplaIndia | 1 September 2016 |
| 30 tablet, extended release in 1 bottle | 33342-276-07 | Macleods PharmaceuticalsIndia | 29 July 2017 |
| 90 tablet, extended release in 1 bottle | 33342-276-10 | Macleods PharmaceuticalsIndia | 29 July 2017 |
| 10 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack | 33342-276-12 | Macleods PharmaceuticalsIndia | 29 July 2017 |
| 500 tablet, extended release in 1 bottle | 13668-202-05 | Torrent PharmaceuticalsIndia | 18 November 2016 |
| 30 tablet, extended release in 1 bottle | 13668-202-30 | Torrent PharmaceuticalsIndia | 18 November 2016 |
| 90 tablet, extended release in 1 bottle | 13668-202-90 | Torrent PharmaceuticalsIndia | 18 November 2016 |
| 30 tablet, film coated, extended release in 1 bottle | 16571-767-03 | Rising Pharma Holdings | 19 September 2016 |
| 90 tablet, film coated, extended release in 1 bottle | 16571-767-09 | Rising Pharma Holdings | 19 September 2016 |
| 30 tablet, extended release in 1 bottle | 72162-2570-3 | Bryant Ranch Prepack | 17 November 2025 |
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
Other strengths and forms of Darifenacin
Clinical summary
Darifenacin is a cholinergic muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. It is available as extended-release tablets for oral use. MedsAcross supplies Darifenacin 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 DarifenacinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Darifenacin prescribing information (Torrent Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Emselex: European public assessment report (EPAR) · European Medicines Agency
Need Darifenacin 7.5 mg extended-release tablet for your hospital or patient?
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