Ursodiol
- Product NDC
- 72603-613
- 11-digit product format
- 726030613
- Labeler code
- 72603
- Product ID
- 72603-613_b762c96f-bb2e-4268-b71c-ccda296cb299
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA214849
- Marketing category
- ANDA
- Marketing start
- 2025-05-01
- Substance
- URSODIOL
- Active strength
- 300 mg/1
- Pharmacologic classes
- Bile Acid [EPC], Bile Acids and Salts [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 724L30Y2QR | URSODIOL | 128-13-2 | URSODIOL |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-613-01 | 72603061301 | 100 CAPSULE in 1 BOTTLE (72603-613-01) | 100 capsule | 2025-05-01 | No | No | Historical |