Ursodiol
- Product NDC
- 70710-1127
- 11-digit product format
- 707101127
- Labeler code
- 70710
- Product ID
- 70710-1127_a9c504cd-4b4b-4de5-af5a-70117f04e4ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA211145
- Marketing category
- ANDA
- Marketing start
- 2018-11-07
- 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 | 858733, 858751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-1127-1 | Ursodiol | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 70710-1127-5 | Ursodiol | 500 in 1 BOTTLE | TABLET | 500 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1127 | URSODIOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240323_55c1556b-8b47-479a-979b-fd61bdd27c7f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70710-1127-1 | 70710112701 | 100 TABLET in 1 BOTTLE (70710-1127-1) | 100 tablet | 2018-11-07 | 0000-00-00 | No | No | Current |
| 70710-1127-5 | 70710112705 | 500 TABLET in 1 BOTTLE (70710-1127-5) | 500 tablet | 2018-11-07 | 0000-00-00 | No | No | Current |