Ursodiol
- Product NDC
- 24658-780
- 11-digit product format
- 246580780
- Labeler code
- 24658
- Product ID
- 24658-780_7e40153a-5dd0-42be-8b9e-fcd68fdcf536
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PuraCap Laboratories, LLC
- Application
- ANDA075517
- Marketing category
- ANDA
- Marketing start
- 2016-12-15
- 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 |
|---|
| 24658-780-01 | Ursodiol | 100 in 1 BOTTLE | CAPSULE | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 24658-780 | URSODIOL CAPSULE [PURACAP LABORATORIES, LLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20241222_9d7f26d5-d8a9-4610-8d78-80ca3d442a79.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 |
|---|
| 24658-780-01 | 24658078001 | 100 CAPSULE in 1 BOTTLE (24658-780-01) | 100 capsule | 2016-12-15 | 0000-00-00 | No | No | Current |