Ursodiol
- Product NDC
- 68001-378
- 11-digit product format
- 680010378
- Labeler code
- 68001
- Product ID
- 68001-378_faf3de2a-e9da-091a-e053-6394a90ae498
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA090801
- Marketing category
- ANDA
- Marketing start
- 2019-02-26
- Substance
- URSODIOL
- Active strength
- 500 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 724L30Y2QR |
| Rxcui | 858733, 858751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68001-378-00 | Ursodiol | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-378 | URSODIOL TABLET [BLUEPOINT LABORATORIES] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230509_a3c98080-0a4d-4a93-8dcb-02ab8533050b.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 |
|---|
| 68001-378-00 | 68001037800 | 100 TABLET in 1 BOTTLE (68001-378-00) | 100 tablet | 2019-02-26 | 0000-00-00 | No | No | Current |