CHOLBAM cholic acid 250 mg Capsule, 90-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Bile Acid class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Cholic Acid — tap one for details:
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
5 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $1,028.25 | $92,542.63 / 90 capsules |
| Medicare drug plans payPart D · Q2 2026 | $1,123.93 | $101,153.55 / 90 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cholbam 250 mgthis 79378-0002-02 | Mirum | 90 capsules | — | — | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 79378-0002-02 You're viewing this | 90 CAPSULE in 1 BOTTLE (79378-002-02) | 2025-05-09 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE CHOLBAM 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.
( 1.3 ).
1.1Bile Acid Synthesis Disorders Due to Single Enzyme Defects CHOLBAM is indicated for the treatment of bile acid synthesis disorders due to single enzyme defects (SEDs). 1.2. Peroxisomal Disorders Including Zellweger Spectrum Disorders CHOLBAM is indicated for 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.
1.3. 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.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • The recommended dosage is 10 to 15 mg/kg once daily or in two divided doses, in pediatric patients and adults. See prescribing information for weight-based dosing tables. ( 2.1 ) • The recommended dosage in patients with concomitant familial hypertriglyceridemia is 11 to 17 mg/kg once daily or in two divided doses and is adjusted based on clinical response.
( 2.1 ) • Monitor AST, ALT, GGT, alkaline phosphatase, bilirubin and INR every month for the first 3 months, every 3 months for the next 9 months, every 6 months during the next three years and annually thereafter. Administer the lowest dose that effectively maintains liver function. ( 2.2 ) • Discontinue CHOLBAM if liver function does not improve within 3 months of starting treatment, if complete biliary obstruction develops, or if there are persistent clinical or laboratory indicators of worsening liver function or cholestasis; continue to monitor liver function and consider restarting at a lower dose when parameters return to baseline.
( 2.2 , 5.1 ) Administration Instructions: • Take with food. ( 2.3 ) • Do not crush or chew the capsules. For patients unable to swallow the capsules, the capsules can be opened and the contents mixed with drink/food ( 2.3 ) 2.1.
Dosage Regimen for Bile Acid Synthesis Disorders Due to SEDs and PDs Including Zellweger Spectrum Disorders The recommended dosage of CHOLBAM is 10 to 15 mg/kg administered orally once daily or in two divided doses, in pediatric patients and adults. Table 1 and Table 2 show the number of capsules that should be administered daily to approximate a dosage of 10 mg/kg/day and 15 mg/kg/day, respectively, using the available 50 mg and 250 mg capsules alone or in combination. Table 1: Number of CHOLBAM Capsules Needed to Achieve a Recommended Dosage of 10 mg/kg/day 10 mg/kg/day Dosage Body Weight (kg) Number of 50 mg capsules Number of 250 mg capsules 4 to 6 1 0 7 to 10 2 0 11 to 15 3 0 16 to 20 4 0 21 to 25 0 1 26 to 30 1 1 31 to 35 2 1 36 to 40 3 1 41 to 45 4 1 46 to 50 0 2 51 to 55 1 2 56 to 60 2 2 61 to 65 3 2 66 to 70 4 2 71 to 75 0 3 76 to 80 1 3 Table 2: Number of CHOLBAM Capsules Needed to Achieve a Recommended Dosage of 15 mg/kg/day 15 mg/kg/day Dosage Body Weight (kg) Number of 50 mg capsules Number of 250 mg capsules 4 to 5 1 0 6 to 9 2 0 10 to 13 3 0 14 to 16 4 0 17 to 19 0 1 20 to 23 1 1 24 to 26 2 1 27 to 29 3 1 30 to 33 4 1 34 to 36 0 2 37 to 39 1 2 40 to 43 2 2 44 to 46 3 2 47 to 49 4 2 50 to 53 0 3 54 to 56 1 3 57 to 59 2 3 60 to 63 3 3 64 to 66 4 3 67 to 69 0 4 70 to 73 1 4 74 to 76 2 4 77 to 79 3 4 80 4 4 Patients with newly diagnosed, or a family history of, familial hypertriglyceridemia may have poor absorption of CHOLBAM from the intestine and require a 10% increase in the recommended dosage to account for losses due to malabsorption.
The recommended dosage of CHOLBAM in patients with concomitant familial hypertriglyceridemia is 11 to 17 mg/kg orally once daily, or in two divided doses. Adequacy of the dosage regimen can be determined by monitoring the patient’s clinical response including steatorrhea and laboratory values of serum transaminases, bilirubin, and prothrombin time/international normalized ratio (PT/INR). 2.2.
Treatment Monitoring Treatment with CHOLBAM should be initiated and monitored by an experienced hepatologist or pediatric gastroenterologist. Monitor serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum gamma glutamyltransferase (GGT), alkaline phosphatase, bilirubin, and INR every month for the first 3 months, every 3 months for the next 9 months, every 6 months during the subsequent three years, and annually thereafter. Monitor more frequently during periods of rapid growth, concomitant disease, and pregnancy.
Administer the lowest dose of CHOLBAM that effectively maintains liver function [see Warnings and Precautions ( 5.1 )] . Discontinue treatment with CHOLBAM if liver function does not improve within 3 months of t…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS CHOLBAM is available in two capsule strengths: • 50 mg capsule: Size number 2 Swedish orange capsule with cap imprinted with “50mg” and body imprinted with “ASK001”. The capsules contain a white to off-white powder. • 250 mg capsule: Size number 0 white capsule with a cap imprinted with “250mg” and body imprinted with “ASK002”. The capsules contain a white to off-white powder. Capsules: 50 mg, 250 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Exacerbation of Liver Impairment: Monitor liver function. Discontinue CHOLBAM if liver function worsens while on treatment. ( 5.1 )
5.1Exacerbation of Liver Impairment In clinical trials, evidence of liver impairment was present before treatment with CHOLBAM in approximately 86% (44/51) of patients with bile acid synthesis disorders due to SEDs and in approximately 50% (14/28) of patients with PDs including Zellweger spectrum disorders. Five of the patients (3 SED and 2 PD) with liver impairment at baseline experienced worsening serum transaminases, elevated bilirubin values, or worsening cholestasis on liver biopsy following treatment. Five additional patients (2 SED and 3 PD) who did not have baseline cholestasis experienced exacerbation of their liver disease while on treatment.
In patients with cirrhosis, cases of severe hepatotoxicity have also been observed following postmarket use of CHOLBAM. Exacerbation of liver impairment by CHOLBAM in these patients cannot be ruled out. Six patients with SEDs underwent liver transplant, including four patients diagnosed with AKR1D1 deficiency, one with 3β-HSD deficiency, and one with CYP7A1 deficiency.
Concurrent elevations of serum GGT and ALT may indicate CHOLBAM overdose [see Dosage and Administration ( 2.2 ) and Overdosage ( 10 )] . Monitor liver function and discontinue CHOLBAM in patients who develop worsening of liver function while on treatment. Discontinue treatment with CHOLBAM at any time if there are clinical or laboratory indicators of worsening liver function or cholestasis [see Dosage and Administration ( 2.2 )].
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reaction is described elsewhere in the labeling: • Exacerbation of Liver Impairment [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (≥1%) are diarrhea, reflux esophagitis, malaise, jaundice, skin lesion, nausea, abdominal pain, intestinal polyp, urinary tract infection, and peripheral neuropathy. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mirum Pharmaceuticals at 1-855-MRM-4YOU or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical safety experience with CHOLBAM consists of: • Trial 1: a non-randomized, open-label, single-arm trial of 50 patients with bile acid synthesis disorders due to SEDs and 29 patients with PDs including Zellweger spectrum disorders.
Safety data are available over the 18 years of the trial. • Trial 2: an extension trial of 12 new patients (10 SED and 2 PD) along with 31 (21 SED and 10 PD) patients who rolled over from Trial 1. Safety data are available for 3 years and 11 months of treatment. Adverse events were not collected systematically in either of these trials.
Most patients received an oral dose of 10 to 15 mg/kg/day of CHOLBAM. Deaths In Trial 1, among the 50 patients with SEDs, 5 patients aged 1 year or less died, which included three patients originally diagnosed with AKR1D1 deficiency, one with 3β-HSD deficiency and one with CYP7A1 deficiency. The cause of death was attributed to progression of underlying liver disease in every patient.
Of 29 patients in Trial 1 with PDs including Zellweger spectrum disorders, 12 patients between the ages of 7 months and 2.5 years died. In the majority of these patients (8/12), the cause of death was attributed to progression of underlying liver disease or to a worsening of their primary illness. Two additional patients in Trial 1 (1 SED and 1 PD) died who had been off study medication for more than one year with the cause of death most likely being a progression of underlying liver disease.
Of the patients who died with disease progression, laboratory testing showed abnormal serum transaminases, bilirubin, or cholestasis on liver biopsy suggesting worsening of their underlying cholestasis. In Trial 2, among the 31 patients with SED, two patients (1 new patient and 1 who rolled over from Trial 1) died. The cause of death in both cases was unrelated to their primary treatment or progression of their underlying liver disease.
Of the 12 patients with PD in Trial 2, four patients died between the ages of 4 and 8 years (1 new patient and 3 who rolled over from Trial 1). The cause of death in three of these patients was attributed to progression of underlying liver disease or to a worsening of their primary illness. Worsening of Liver Impairment Seven patients in Trial 1 (4 SED and 3 PD) and 3 patients in Trial 2 (1 SED and 2 PD) experienced worsening serum transaminases, elevated bilirubin values, or worsening cholestasis on liver biopsy during treatment [see Warnings and Precautions ( 5.1 )] .
Common Adverse Reactions There were 12 adverse reactions reported across 9 patients in the trials, with diarrhea being the most common reaction in approximately 2% of the patient population. All other adverse reactions represented 1% of the patient population. The breakdown by trial follows: Table 3: Most Common Adverse Reactions in Trials 1 and 2 *Adverse reactions that occurred in new patients Adverse Reactions Trial 1 Trial 2* Overall n (%) Diarrhea 1 2* 3 (2) Reflux Esophagitis 1 0 1 (1) Malaise 1 0 1 (1) Jaundice 1 0 1 (1) Skin lesion 1 0 1 (1) Nausea 0 1* 1 (1) Abdominal Pain 0 1* 1 (1) Intestinal Polyp 0 1* 1 (1) Urinary Tract Infection 0 1* 1 (1) Peripheral Neuropathy 0 1 1 (1)…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Bile Salt Efflux Pump (BSEP) Inhibitors (e.g., cyclosporine): Avoid concomitant use; if concomitant use is necessary, monitor serum transaminases and bilirubin ( 7.1 ) • Bile Acid Resins and Aluminum-Based Antacids: Take CHOLBAM at least 1 hour before or 4 to 6 hours (or at as great an interval as possible) after a bile acid binding resin or aluminum-based antacids. ( 2.3 , 7.1 ) 7.1. Effects of Other Drugs on CHOLBAM Drug interactions with CHOLBAM mainly relate to agents capable of interrupting the enterohepatic circulation of bile acids.
Inhibitors of Bile Acid Transporters Avoid concomitant use of inhibitors of the bile salt efflux pump (BSEP) such as cyclosporine. Concomitant medications that inhibit canalicular membrane bile acid transporters such as the BSEP may exacerbate accumulation of conjugated bile salts in the liver and result in clinical symptoms. If concomitant use is deemed necessary, monitoring of serum transaminases and bilirubin is recommended.
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. Take CHOLBAM at least 1 hour before or 4 to 6 hours (or at as great an interval as possible) after a bile acid binding resin [see Dosage and Administration ( 2.3 )] . Aluminum-Based Antacids Aluminum-based antacids have been shown to adsorb bile acids in vitro and can reduce the availability of CHOLBAM.
Take CHOLBAM at least 1 hour before or 4 to 6 hours (or at as great an interval as possible) after an aluminum-based antacid [see Dosage and Administration ( 2.3 )] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Surveillance Program There is a pregnancy surveillance program that monitors pregnancy outcomes in women exposed to CHOLBAM during pregnancy. Women who become pregnant during CHOLBAM treatment are encouraged to enroll. Patients or their health care provider should call Mirum Medical Information 1-855-676-4968.
Risk Summary No studies in pregnant women or animal reproduction studies have been conducted with CHOLBAM. Limited published case reports discuss pregnancies in women taking cholic acid for 3β-HSD deficiency resulting in healthy infants. These reports may not adequately inform the presence or absence of drug-associated risk with the use of CHOLBAM during pregnancy.
The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.
8.2Lactation Risk Summary Endogenous cholic acid is present in human milk. Clinical lactation studies have not been conducted to assess the presence of CHOLBAM in human milk, the effects of CHOLBAM on the breastfed infant, or the effects of CHOLBAM on milk production. There are no animal lactation data and no data from case reports available in the published literature.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CHOLBAM and any potential adverse effects on the breastfed infant from CHOLBAM or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of CHOLBAM have been established in pediatric patients 3 weeks of age and older for the treatment of bile acid synthesis disorders due to SEDs and for adjunctive treatment of patients with PDs including Zellweger spectrum disorders who exhibit manifestations of liver disease, steatorrhea, or complications from decreased fat-soluble vitamin absorption [see Clinical Studies ( 14 )] .
8.5Geriatric Use Clinical studies of CHOLBAM did not include any patients aged 65 years and over. It is not known if elderly patients respond differently from younger patients. 8.6.
Hepatic Impairment Discontinue treatment with CHOLBAM if liver function does not improve within 3 months of the start of treatment. Discontinue treatment with CHOLBAM at any time if there are clinical or laboratory indicators of worsening liver function or cholestasis [see Warnings and Precautions ( 5.1 ), Overdosage ( 10 ), and Nonclinical Toxicology ( 13.2 )]. Continue to monitor laboratory parameters of liver function and consider restarting at a lower dose when the parameters return to baseline.
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Surveillance Program There is a pregnancy surveillance program that monitors pregnancy outcomes in women exposed to CHOLBAM during pregnancy. Women who become pregnant during CHOLBAM treatment are encouraged to enroll. Patients or their health care provider should call Mirum Medical Information 1-855-676-4968.
Risk Summary No studies in pregnant women or animal reproduction studies have been conducted with CHOLBAM. Limited published case reports discuss pregnancies in women taking cholic acid for 3β-HSD deficiency resulting in healthy infants. These reports may not adequately inform the presence or absence of drug-associated risk with the use of CHOLBAM during pregnancy.
The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of CHOLBAM have been established in pediatric patients 3 weeks of age and older for the treatment of bile acid synthesis disorders due to SEDs and for adjunctive treatment of patients with PDs including Zellweger spectrum disorders who exhibit manifestations of liver disease, steatorrhea, or complications from decreased fat-soluble vitamin absorption [see Clinical Studies ( 14 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of CHOLBAM did not include any patients aged 65 years and over. It is not known if elderly patients respond differently from younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE Concurrent elevations of serum GGT and ALT may indicate CHOLBAM overdose. If an overdose is suspected, discontinue CHOLBAM and treat symptoms. Continue to monitor laboratory parameters of liver function and consider restarting at a lower dose when the parameters return to baseline [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Cholic acid is a primary bile acid synthesized from cholesterol in the liver. In bile acid synthesis disorders due to SEDs in the biosynthetic pathway, and in PDs including Zellweger spectrum disorders, deficiency of primary bile acids leads to unregulated accumulation of intermediate bile acids and cholestasis. Bile acids facilitate fat digestion and absorption by forming mixed micelles and facilitate absorption of fat-soluble vitamins in the intestine.
Endogenous bile acids including cholic acid enhance bile flow and provide the physiologic feedback inhibition of bile acid synthesis. The mechanism of action of cholic acid has not been fully established; however, it is known that cholic acid and its conjugates are endogenous ligands of the nuclear receptor, farnesoid X receptor (FXR). FXR regulates enzymes and transporters that are involved in bile acid synthesis and in the enterohepatic circulation to maintain bile acid homeostasis under normal physiologic conditions.
12.3Pharmacokinetics Orally administered cholic acid is subject to the same metabolic pathway as endogenous cholic acid. Cholic acid is absorbed by passive diffusion along the length of the gastrointestinal tract. Once absorbed, cholic acid enters into the body’s bile acid pool and undergoes enterohepatic circulation mainly in conjugated forms.
In the liver, cholic acid is conjugated with glycine or taurine by bile acid-CoA synthetase and bile acid-CoA:amino acid N-acyltransferase. Conjugated cholic acid is actively secreted into bile by the BSEP, and then released into the small intestines, along with other components of bile. Conjugated cholic acid is mostly re-absorbed in the ileum mainly by the apical-sodium-dependent-bile acid transporter, passed back to the liver by transporters including sodium-taurocholate cotransporting polypeptide and organic anion transport protein and enters another cycle of enterohepatic circulation.
Any conjugated cholic acid not absorbed in the ileum passes into the colon where deconjugation and 7-dehydroxylation are mediated by bacteria to form cholic acid and deoxycholic acid, which may be re-absorbed in the colon or excreted in the feces. The loss of cholic acid is compensated by de-novo synthesis of cholic acids from cholesterol to maintain the bile acid pool in healthy subjects.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Cholic acid is a primary bile acid synthesized from cholesterol in the liver. In bile acid synthesis disorders due to SEDs in the biosynthetic pathway, and in PDs including Zellweger spectrum disorders, deficiency of primary bile acids leads to unregulated accumulation of intermediate bile acids and cholestasis. Bile acids facilitate fat digestion and absorption by forming mixed micelles and facilitate absorption of fat-soluble vitamins in the intestine.
Endogenous bile acids including cholic acid enhance bile flow and provide the physiologic feedback inhibition of bile acid synthesis. The mechanism of action of cholic acid has not been fully established; however, it is known that cholic acid and its conjugates are endogenous ligands of the nuclear receptor, farnesoid X receptor (FXR). FXR regulates enzymes and transporters that are involved in bile acid synthesis and in the enterohepatic circulation to maintain bile acid homeostasis under normal physiologic conditions.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 50 mg Capsules CHOLBAM capsules are available as two-piece gelatin capsules with a Swedish orange cap imprinted with “50mg” and Swedish orange body imprinted with “ASK001”. The capsules contain a white or off-white powder and are supplied in bottles of: • 90 capsules (NDC 79378-001-02) 250 mg Capsules CHOLBAM capsules are available as two-piece gelatin capsules with a white cap imprinted with “250mg” and white body imprinted with “ASK002”. The capsules contain a white or off-white powder and are supplied in bottles of: • 90 capsules (NDC 79378-002-02) Storage and Handling Store at 20°C–25 ○ C (68°F–77 ○ F), excursions permitted between 15°C–30 ○ C (59°F–86 ○ F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Cholic acid is a bile acid. The chemical formula is C 24 H 40 O 5 , the molecular weight is 408.57 and the chemical structure is: Cholic acid is a white to off-white powder. It is practically insoluble in water and in
0.1 M HCl at 20°C and is sparingly soluble in
0.1M NaOH at 20°C. It is soluble in glacial acetic acid, alcohols, and acetone. A saturated solution in water at 20°C has a pH of 4.4.
CHOLBAM capsules contain 50 mg or 250 mg of cholic acid as the active ingredient in size 2 Swedish orange or size 0 white opaque gelatin capsules, respectively. Inactive ingredients in CHOLBAM include crospovidone, magnesium stearate, and silicified microcrystalline cellulose. The size 2 capsule shells contain gelatin, red iron oxide and titanium dioxide, and the size 0 capsule shells contain gelatin and titanium dioxide.
CHOLBAM is administered orally. Cholic acid chemical structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Exacerbation of Liver Impairment [see Warnings and Precautions ( 5.1 )] • Advise patients that they will need to undergo laboratory testing periodically while on treatment to assess liver function. • Advise patients that CHOLBAM may worsen liver impairment and that they should immediately report to their health care provider any symptoms associated with liver impairment (e.g., yellowing of the skin or the whites of the eye, dark or tea-colored urine, pain on the right side of stomach, bleeding or bruising occurs more easily than normal, or increased lethargy) Administration [see Dosage and Administration ( 2.3 ) ] Advise patients: • to take CHOLBAM with food. • to take CHOLBAM at least one hour before or 4 to 6 hours after taking a bile acid binding resin or an aluminum-based antacid. • not to crush or chew the capsules. • for infants and children who cannot swallow capsules, the capsules can be opened and the contents mixed with either infant formula or expressed breast milk (for younger children), or soft food such as mashed potatoes or apple puree (for older children and adults) in order to mask any unpleasant taste: 1.
Hold the capsule over the prepared liquid/food, gently twist open, and allow the contents to fall into the liquid/food. 2. Mix the entire capsule contents with one or two tablespoonfuls (15 mL or 30 mL) of infant formula, expressed breast milk, or soft food such as mashed potatoes or apple puree.
3. Stir for 30 seconds. 4.
The capsule contents will remain as fine granules in the milk or food and will not dissolve. 5. Administer the mixture immediately.
Pregnancy Surveillance Program [see Use in Specific Populations ( 8.1 )] Inform patients about the pregnancy surveillance program that monitors pregnancy outcomes in women exposed to CHOLBAM during pregnancy. Manufactured by: Patheon France S.A.S. 38300 Bourgoin-Jallieu, France Manufactured for: Mirum Pharmaceuticals, Inc.
Foster City, CA 94404 © 2026 Mirum Pharmaceuticals, Inc. CHOLBAM ® is a registered trademark of Mirum Pharmaceuticals, Inc. LB00132v2