Prescription medicine
Cholic acid Brand names: Cholbam
Cholic acid (Cholbam) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the cholic acid FDA label on DailyMed (effective January 26, 2026, Mirum Pharmaceuticals Inc.); the NDA 205750 record on Drugs@FDA; every cholic acid label on DailyMed.
Highlights of the record
FDA label of January 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCHOLBAM is a bile acid indicated for:
Treatment of bile acid synthesis disorders due to single enzyme defects (SEDs).
Forms and strengths
- 50 mg
- 250 mg
Capsule.
On the market
- Earliest approval on file
- March 17, 2015 Cholbam, Mirum; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 397 through July 30, 2026
What is cholic acid used for?
From the label: indications and usageCHOLBAM is a bile acid indicated for:
Treatment of bile acid synthesis disorders due to single enzyme defects (SEDs). ( 1.1 )
Adjunctive treatment of peroxisomal disorders (PDs) including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea or complications from decreased fat-soluble vitamin absorption. ( 1.2 ) Limitations of use: The safety and effectiveness of CHOLBAM on extrahepatic manifestations of bile acid synthesis disorders due to SEDs or PDs including Zellweger spectrum disorders have not been established. […]
FDA pharmacologic class: Bile Acid.
Source: FDA drug label (CHOLBAM), Mirum Pharmaceuticals Inc., effective January 26, 2026 (SPL set 5c6e4c9d-b85e-493f-9420-ab2fd0ff3723), via openFDA; the full label on DailyMed
Is there a generic for cholic acid (Cholbam)?
No generic cholic acid is approved (Drugs@FDA, October 8, 2026).
- 2015 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the cholic acid label say about other medicines?
The cholic acid label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cholestyramine | drug interactions | Bile Acid Binding Resins Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the efficacy of CHOLBAM. |
| Colesevelam | drug interactions | Bile Acid Binding Resins Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the efficacy of CHOLBAM. |
| Colestipol | drug interactions | Bile Acid Binding Resins Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the efficacy of CHOLBAM. |
| Cyclosporine | drug interactions | Bile Salt Efflux Pump (BSEP) Inhibitors (e.g., cyclosporine): Avoid concomitant use; if concomitant use is necessary, monitor serum transaminases and bilirubin |
Source: FDA drug label (CHOLBAM), Mirum Pharmaceuticals Inc., effective January 26, 2026 (SPL set 5c6e4c9d-b85e-493f-9420-ab2fd0ff3723), via openFDA; the full label on DailyMed
What do FAERS reports show for cholic acid?
The FDA Adverse Event Reporting System holds 397 reports that list cholic acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 72 are coded as a death and 89 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other bile acids
- the pharmacologic class, with prices and generics
- Cholic acid side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other