Ursodiol
- Product NDC
- 69238-1540
- 11-digit product format
- 692381540
- Labeler code
- 69238
- Product ID
- 69238-1540_5669f4be-fc2b-4231-b9d2-30159562b284
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA211301
- Marketing category
- ANDA
- Marketing start
- 2018-10-22
- Substance
- URSODIOL
- Active strength
- 300 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
- Ursodiol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| URSODIOL | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 724L30Y2QR |
| Rxcui | 858747 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-1540-1 | Ursodiol | 100 in 1 BOTTLE | CAPSULE | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1540 | URSODIOL CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] | 8 | Current NDC, Legacy NDC, 1 package rows | 20250427_1027b933-f64f-4a43-996f-a676b5f72da0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69238-1540-1 | 69238154001 | 100 CAPSULE in 1 BOTTLE (69238-1540-1) | 100 capsule | 2018-10-22 | 0000-00-00 | No | No | Current |