Ursodiol
- Product NDC
- 63629-8353
- 11-digit product format
- 636298353
- Labeler code
- 63629
- Product ID
- 63629-8353_8b2c5225-0b03-4789-b253-bdef17cb67ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202540
- Marketing category
- ANDA
- Marketing start
- 2013-08-01
- Marketing end
- 0000-00-00
- Substance
- URSODIOL
- Active strength
- 250 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8353-1 | 63629835301 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-8353-1) | 2020-11-09 | 0000-00-00 | No | No | Current |