CHOLBAM
- Product NDC
- 79378-002
- 11-digit product format
- 793780002
- Labeler code
- 79378
- Product ID
- 79378-002_edddbf7e-e2dd-4ff7-80a0-d73c22fd40ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cholic acid
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mirum Pharmaceuticals Inc.
- Application
- NDA205750
- Marketing category
- NDA
- Marketing start
- 2025-05-09
- Substance
- CHOLIC ACID
- Active strength
- 250 mg/1
- Pharmacologic classes
- Bile Acid [EPC], Bile Acids and Salts [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CHOLBAM
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHOLIC ACID | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G1JO7801AE |
| Rxcui | 1440861, 1440868, 1608274, 1608276 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 79378-002-02 | CHOLBAM | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 79378-002 | CHOLBAM (CHOLIC ACID) CAPSULE [MIRUM PHARMACEUTICALS INC.] | 1 | Current NDC, 1 package rows | 20250509_5c6e4c9d-b85e-493f-9420-ab2fd0ff3723.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 79378-002-02 | 79378000202 | 90 CAPSULE in 1 BOTTLE (79378-002-02) | 90 capsule | 2025-05-09 | No | No | Current |