Ursodiol
- Product NDC
- 60687-527
- 11-digit product format
- 606870527
- Labeler code
- 60687
- Product ID
- 60687-527_437ecc8a-2e45-94a1-e063-6394a90acc85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA211145
- Marketing category
- ANDA
- Marketing start
- 2020-09-11
- Substance
- URSODIOL
- Active strength
- 250 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 |
|---|
| 60687-527-21 | 60687052721 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-527-21) / 1 TABLET in 1 BLISTER PACK (60687-527-11) | 30 blister pack | 2020-09-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ursodiol | American Health Packaging | 2025-11-13 | HUMAN PRESCRIPTION DRUG LABEL | 4 |