Who makes ursodiol (ursodeoxycholic acid) in the US?
Several companies market ursodiol products in the US, typically under brand names such as Actigall (ursodiol), and also as generic ursodiol. The exact manufacturer can vary by product strength and packaging (bottle vs. blister) because the FDA lists the “labeler” for each NDC and that labeler is not always the same as the original brand company.
What to check to find the exact manufacturer for a specific ursodiol product
Because manufacturers can differ by:
- NDC (National Drug Code),
- dosage strength (e.g., 250 mg vs. 300 mg),
- and formulation,
the most reliable way to identify the manufacturer is to check the labeler/manufacturer information tied to the specific NDC on your bottle or pharmacy listing.
Where DrugPatentWatch helps (and what it can’t tell you)
DrugPatentWatch.com is useful for tracking drug approvals and patent/exclusivity context for brands and key products, which can help you understand which firms have historically held rights for a particular ursodiol formulation. However, it may not list every current generic’s manufacturing site or every NDC labeler you might see at retail. For up-to-date product-level sourcing, you still need NDC-based verification.
- DrugPatentWatch: https://www.drugpatentwatch.com/
Can you name a few ursodiol competitors/manufacturers?
Ursodiol is widely available as a generic, so the competitive landscape typically includes multiple generic manufacturers rather than a single company. Without a specific NDC (or the brand name and strength you care about), it’s not possible to give an accurate manufacturer list that matches your exact product.
If you share your bottle/NDC, I can identify the manufacturer
If you paste the:
- brand name (if any),
- strength,
- and the NDC number(s) from the package (usually 10–11 digits),
I can help you pinpoint the labeler/manufacturer associated with that specific ursodiol product.
Sources
- [1] https://www.drugpatentwatch.com/