Medicine
Flavoxate 100 mg tablet
Flavoxate 100 mg tablet is a generic prescription medicine for oral use, made by 3 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) Manufactured For Padagis ® Minneapolis, MN…
Key facts
- Active ingredient (INN)
- Flavoxate
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets and 1 more
- Manufacturers
- Epic PharmaBlu PharmaceuticalsPadagis
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F) Manufactured For Padagis ® Minneapolis, MN 55427 www.padagis.com Rev 05-23 7H700 RC PH3 Code 917A00
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G04BD02 Flavoxate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 December 2004
- Identifiers
- RxCUI 1095229DailyMed set ID a9c44c4b-5b3c-45bf-9bc9-ce858e3d06c5, f6a06eda-2480-4c0d-8d1e-9e3e89d3ee88, b4260d7e-2ab3-49f6-aa57-bae19a23d82aNDC 0574-0115, 24658-720, 42806-058Application ANDA076831, ANDA076835
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 in 1 bottle | 24658-720-01 | Blu Pharmaceuticals | 15 December 2016 |
| 100 tablet in 1 bottle | 42806-058-01 | Epic Pharma | 21 February 2011 |
| 1000 tablet in 1 bottle | 42806-058-10 | Epic Pharma | 21 February 2011 |
| 100 tablet, film coated in 1 bottle, plastic | 0574-0115-01 | Padagis | 22 December 2004 |
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 15 January 1970 | 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
Clinical summary
Flavoxate is a cholinergic muscarinic antagonist indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. It is available as tablets for oral use. MedsAcross supplies Flavoxate 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 FlavoxateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Flavoxate Hydrochloride prescribing information (Blu Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Flavoxate 100 mg tablet 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.