Ursodiol
- Product NDC
- 0904-7168
- 11-digit product format
- 009047168
- Labeler code
- 0904
- Product ID
- 0904-7168_27238e3b-937e-4d18-85b7-0f69bc9e8761
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA211301
- Marketing category
- ANDA
- Marketing start
- 2018-10-22
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7168 | URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] | 4 | Legacy NDC | 20250119_27238e3b-937e-4d18-85b7-0f69bc9e8761.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-7168-06 | 00904716806 | 50 BLISTER PACK in 1 CARTON (0904-7168-06) > 1 CAPSULE in 1 BLISTER PACK | 50 blister pack | 2018-10-22 | 0000-00-00 | No | No | Current |
| 0904-7168-61 | 00904716861 | 100 BLISTER PACK in 1 CARTON (0904-7168-61) > 1 CAPSULE in 1 BLISTER PACK | 100 blister pack | 2018-10-22 | 0000-00-00 | No | No | Current |