Ursodiol 400 mg
- Product NDC
- 79739-7144
- 11-digit product format
- 797397144
- Labeler code
- 79739
- Product ID
- 79739-7144_efdeb26d-50b6-4a2f-886a-fcb59ea7fee0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Usodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- LGM PHARMA SOLUTIONS, LLC
- Application
- ANDA205789
- Marketing category
- ANDA
- Marketing start
- 2020-07-01
- Substance
- URSODIOL
- Active strength
- 400 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 400 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| URSODIOL | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 724L30Y2QR |
| Rxcui | 412174, 2376942 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 79739-7144-1 | Ursodiol 400 mg | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 79739-7144 | URSODIOL 200 MG (USODIOL) CAPSULE URSODIOL 400 MG (USODIOL) CAPSULE [LGM PHARMA SOLUTIONS, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241123_ebaaa3e2-1d80-4b40-b696-88cdd06448e4.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 |
|---|
| 79739-7144-1 | 79739714401 | 100 CAPSULE in 1 BOTTLE (79739-7144-1) | 100 capsule | 2020-07-01 | 0000-00-00 | No | No | Current |