Ursodiol
- Product NDC
- 0527-1326
- 11-digit product format
- 005271326
- Labeler code
- 0527
- Product ID
- 0527-1326_2a1b76c4-6aa9-4132-ae02-177791eb7560
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA079082
- Marketing category
- ANDA
- Marketing start
- 2009-01-01
- Substance
- URSODIOL
- Active strength
- 300 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 | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 724L30Y2QR |
| Rxcui | 858747 |
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 |
|---|
| 0527-1326-01 | Ursodiol | 100 in 1 BOTTLE | CAPSULE | 100 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-1326 | URSODIOL CAPSULE [LANNETT COMPANY, INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20240704_2e799e93-b5a0-40f7-95c5-b40d8a948a0d.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 |
|---|
| 0527-1326-01 | 00527132601 | 100 CAPSULE in 1 BOTTLE (0527-1326-01) | 100 capsule | 2009-01-01 | 0000-00-00 | No | No | Current |