Prescription drug · NDA
Cholbam (Cholic acid) NDC 79378-001
Cholic acid 50 mg/1 · Capsule · Oral · Mirum Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 79378-001-02 | 79378000102 | 90 CAPSULE in 1 BOTTLE (79378-001-02)Marketed from May 9, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cholbam
- Generic name (nonproprietary)
- cholic acid
- Active ingredients
- Cholic acid — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Mirum Pharmaceuticals Inc.NDC labeler code 79378
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205750
- Marketing start
- Listing expires
- Other FDA classes
- Bile Acids and Salts (Chemical structure)
- Identifiers
- Product ID 79378-001_edddbf7e-e2dd-4ff7-80a0-d73c22fd40ceSPL ID edddbf7e-e2dd-4ff7-80a0-d73c22fd40ceSPL set ID 5c6e4c9d-b85e-493f-9420-ab2fd0ff3723RxCUI 1440861, 1440868, 1608274, 1608276UNII G1JO7801AE
- Pharmacologic class
- Bile Acid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N479378000102followed by a unit qualifier and the quantityPackage 79378-0001-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
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 ). 1.1 Bile Acid Synthesis Disorders Due to Single Enzyme Defects CHOLBAM is indicated for the treatment of bile acid synth…
Excerpt only. Read the full label for complete information.
About NDC 79378-001
- What is NDC 79378-001?
- 79378-001 is the product NDC for Cholbam (cholic acid), Cholic acid 50 mg/1 capsule, listed with the FDA by Mirum Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cholbam (Cholic acid).
- What is the active ingredient?
- Cholic acid.
- Who is the labeler?
- Mirum Pharmaceuticals Inc., NDC labeler code 79378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cholbam?
- 1 other product NDC are listed under this name. See all Cholbam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cholbam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cholbamcholic acid | Cholic acid 250 mg/1 | CapsuleOral | Mirum Pharmaceuticals Inc. | 79378-002 | 79378-0002-02 |
Other NDCs under NDA 205750
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cholbamcholic acid | Cholic acid 250 mg/1 | CapsuleOral | Mirum Pharmaceuticals Inc. | 79378-002 |