Ctexli (chenodiol) NDC 79378-310

NDC codes

FDA NDC Directory

Product NDC (as listed)79378-310Labeler and product segments. Claims need a package NDC.

Product NDC at billing width79378-0310Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
79378-310-90	79378031090	100 TABLET, FILM COATED in 1 BOTTLE (79378-310-90)Marketed from Apr 4, 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): Ctexli
Generic name (nonproprietary): chenodiol
Active ingredients: Chenodiol — 250 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mirum Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 219488
Marketing start: Apr 4, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Bile Acids and Salts (Chemical structure)
Identifiers: Product ID 79378-310_71b050b3-07a6-401f-9526-104383bff7b7SPL ID 71b050b3-07a6-401f-9526-104383bff7b7SPL set ID 015384e7-4ac5-4782-a309-e40cd1421c5bRxCUI 618469, 2710422UNII 0GEI24LG0J
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

N479378031090 followed by a unit qualifier and the quantity

Package 79378-0310-90. 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 Dec 16, 2025.

Indications (excerpt from the label)

CTEXLI is indicated for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. CTEXLI is a bile acid indicated for treatment of cerebrotendinous xanthomatosis (CTX) in adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)