Ursodiol
- Product NDC
- 0378-1730
- 11-digit product format
- 003781730
- Labeler code
- 0378
- Product ID
- 0378-1730_1a1a527a-388c-4939-b82e-9fea9ad01714
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA090530
- Marketing category
- ANDA
- Marketing start
- 2016-01-05
- Marketing end
- 2023-01-31
- Substance
- URSODIOL
- Active strength
- 300 mg/1
- Pharmacologic classes
- Bile Acid [EPC],Bile Acids and Salts [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-1730-01 | 00378173001 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1730-01) | 100 capsule | 2016-01-05 | 2023-01-31 | No | No | Current |