Ursodiol
- Product NDC
- 71930-015
- 11-digit product format
- 719300015
- Labeler code
- 71930
- Product ID
- 71930-015_c98d6217-b305-4615-9c70-7259d94ca205
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Eywa Pharma Inc
- Application
- ANDA212452
- Marketing category
- ANDA
- Marketing start
- 2020-02-05
- Marketing end
- 0000-00-00
- Substance
- URSODIOL
- Active strength
- 300 mg/1
- Pharmacologic classes
- Bile Acid [EPC],Bile Acids and Salts [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71930-015 | URSODIOL CAPSULE [EYWA PHARMA INC] | 3 | Legacy NDC | 20231216_c98d6217-b305-4615-9c70-7259d94ca205.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71930-015-12 | 71930001512 | 100 CAPSULE in 1 BOTTLE (71930-015-12) | 100 capsule | 2020-02-05 | 0000-00-00 | No | No | Current |