CTEXLI
- Product NDC
- 79378-310
- 11-digit product format
- 793780310
- Labeler code
- 79378
- Product ID
- 79378-310_71b050b3-07a6-401f-9526-104383bff7b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- chenodiol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mirum Pharmaceuticals Inc.
- Application
- NDA219488
- Marketing category
- NDA
- Marketing start
- 2025-04-04
- Substance
- CHENODIOL
- Active strength
- 250 mg/1
- Pharmacologic classes
- Bile Acid [EPC], Bile Acids and Salts [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CTEXLI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHENODIOL | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0GEI24LG0J |
| Rxcui | 618469, 2710422 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 79378-310-90 | CTEXLI | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 79378-310 | CTEXLI (CHENODIOL) TABLET, FILM COATED [MIRUM PHARMACEUTICALS INC.] | 1 | Current NDC, 1 package rows | 20250406_015384e7-4ac5-4782-a309-e40cd1421c5b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 79378-310-90 | 79378031090 | 100 TABLET, FILM COATED in 1 BOTTLE (79378-310-90) | 2025-04-04 | No | No | Current |