Ursodiol
- Product NDC
- 63629-1048
- 11-digit product format
- 636291048
- Labeler code
- 63629
- Product ID
- 63629-1048_99b1e957-39ab-44b4-b039-c30a8e50578c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075517
- Marketing category
- ANDA
- Marketing start
- 2011-04-15
- 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
- 2023-12-31
- 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 |
|---|
| 63629-1048-1 | 63629104801 | 100 CAPSULE in 1 BOTTLE (63629-1048-1) | 100 capsule | 2019-07-01 | 0000-00-00 | No | No | Current |