Ursodiol
- Product NDC
- 55154-2633
- 11-digit product format
- 551542633
- Labeler code
- 55154
- Product ID
- 55154-2633_cc868448-2155-45e6-a13b-72bc0d0f0fc8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA202540
- Marketing category
- ANDA
- Marketing start
- 2024-10-31
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ursodiol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| URSODIOL | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 724L30Y2QR |
| Rxcui | 858751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-2633-0 | Ursodiol | 10 in 1 BAG | TABLET, FILM COATED | 10 | | 3 |
| 55154-2633-0 | Ursodiol | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-2633 | URSODIOL TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] | 2 | Current NDC, 2 package rows | 20250326_61dcaec8-3acb-4ef0-afde-65a66e99afa7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55154-2633-0 | 55154263300 | 10 BLISTER PACK in 1 BAG (55154-2633-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2024-10-31 | No | No | Historical |