URSODIOL
- Product NDC
- 51407-754
- 11-digit product format
- 514070754
- Labeler code
- 51407
- Product ID
- 51407-754_0631dc59-4622-8f2d-e063-6294a90a1a7b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA210344
- Marketing category
- ANDA
- Marketing start
- 2021-01-22
- Marketing end
- 2027-12-31
- 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
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 |
|---|
| 51407-754-01 | URSODIOL | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51407-754 | URSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] | 3 | Current NDC, 1 package rows | 20230926_fb317988-a4e3-9c9a-e053-6294a90a5990.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 |
|---|
| 51407-754-01 | 51407075401 | 100 CAPSULE in 1 BOTTLE (51407-754-01) | 100 capsule | 2023-05-05 | 2027-12-31 | No | No | Historical |