Ursodiol
- Product NDC
- 42291-931
- 11-digit product format
- 422910931
- Labeler code
- 42291
- Product ID
- 42291-931_48c0d20b-d59e-c74b-e063-6394a90a1f3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA202540
- Marketing category
- ANDA
- Marketing start
- 2023-12-14
- Substance
- URSODIOL
- Active strength
- 500 mg/1
- Pharmacologic classes
- Bile Acid [EPC], Bile Acids and Salts [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ursodiol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| URSODIOL | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 724L30Y2QR |
| Rxcui | 858733 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-931-01 | Ursodiol | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-931 | URSODIOL TABLET, FILM COATED [AVKARE] | 1 | Current NDC, 1 package rows | 20231215_0c7e1aa2-704c-435d-e063-6394a90a2d08.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-931-01 | 42291093101 | 100 TABLET, FILM COATED in 1 BOTTLE (42291-931-01) | 2023-12-14 | No | No | Current |