Ursodiol
- Product NDC
- 68001-344
- 11-digit product format
- 680010344
- Labeler code
- 68001
- Product ID
- 68001-344_dee51185-b602-4c3f-a8ce-6aece1296081
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA200826
- Marketing category
- ANDA
- Marketing start
- 2014-02-27
- Marketing end
- 0000-00-00
- Substance
- URSODIOL
- Active strength
- 500 mg/1
- Pharmacologic classes
- Bile Acid [EPC],Bile Acids and Salts [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 68001-344-00 | 68001034400 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-344-00) | 2014-02-27 | 0000-00-00 | No | No | Current |