Ursodiol
- Product NDC
- 64980-483
- 11-digit product format
- 649800483
- Labeler code
- 64980
- Product ID
- 64980-483_fe8d6ce3-4c51-4b9e-8e1a-90aaf5f2b1a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rising Pharmaceuticals, Inc.
- Application
- ANDA213200
- Marketing category
- ANDA
- Marketing start
- 2020-02-12
- 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
- 2021-12-31
- 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 |
|---|
| 64980-483-01 | 64980048301 | 100 CAPSULE in 1 BOTTLE (64980-483-01) | 100 capsule | 2020-02-12 | 0000-00-00 | No | No | Current |
| 64980-483-03 | 64980048303 | 30 CAPSULE in 1 BOTTLE (64980-483-03) | 30 capsule | 2020-02-12 | 0000-00-00 | No | No | Current |
| 64980-483-50 | 64980048350 | 500 CAPSULE in 1 BOTTLE (64980-483-50) | 500 capsule | 2020-02-12 | 0000-00-00 | No | No | Current |