Ursodiol
- Product NDC
- 69025-128
- 11-digit product format
- 690250128
- Labeler code
- 69025
- Product ID
- 69025-128_c95b11ac-4350-06c5-e053-2a95a90a9054
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aizant Drug Research Solutions Pvt Ltd
- Application
- ANDA214329
- Marketing category
- ANDA
- Marketing start
- 2021-07-28
- 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
- 2022-12-31
- 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 |
|---|
| 69025-128-01 | 69025012801 | 100 CAPSULE in 1 BOTTLE, PLASTIC (69025-128-01) | 100 capsule | 2021-07-28 | 0000-00-00 | No | No | Current |