Ursodiol
- Product NDC
- 70771-1524
- 11-digit product format
- 707711524
- Labeler code
- 70771
- Product ID
- 70771-1524_5cab9ae3-fb31-4848-9115-460a8b693042
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA214295
- Marketing category
- ANDA
- Marketing start
- 2021-01-21
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 724L30Y2QR | URSODIOL | 128-13-2 | URSODIOL |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1524-1 | 70771152401 | 100 CAPSULE in 1 BOTTLE (70771-1524-1) | 100 capsule | 2021-01-21 | No | No | Historical |