Ursodiol
- Product NDC
- 51079-383
- 11-digit product format
- 510790383
- Labeler code
- 51079
- Product ID
- 51079-383_d126d870-95f5-bb75-e053-2995a90ad67d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA090530
- Marketing category
- ANDA
- Marketing start
- 2016-01-25
- Marketing end
- 2023-01-31
- Substance
- URSODIOL
- Active strength
- 300 mg/1
- Pharmacologic classes
- Bile Acid [EPC],Bile Acids and Salts [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|
| 51079-383-20 | 51079038320 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-383-20) > 1 CAPSULE in 1 BLISTER PACK (51079-383-01) | 100 blister pack | 2016-01-25 | 0000-00-00 | No | No | Current |