Ursodiol
- Product NDC
- 10702-237
- 11-digit product format
- 107020237
- Labeler code
- 10702
- Product ID
- 10702-237_351bd434-3965-1167-e063-6294a90a1530
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursosiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- KVK-Tech, Inc.
- Application
- ANDA210707
- Marketing category
- ANDA
- Marketing start
- 2018-05-17
- Substance
- URSADIOL
- Active strength
- 300 mg/1
- 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 |
|---|
| URSADIOL | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3D089V7L0K |
| 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 |
|---|
| 10702-237-01 | Ursodiol | 100 in 1 BOTTLE | CAPSULE | 100 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10702-237 | URSODIOL (URSOSIOL) CAPSULE [KVK-TECH, INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20250515_fff2640b-b704-4303-acae-8647fce58a08.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 |
|---|
| 10702-237-01 | 10702023701 | 100 CAPSULE in 1 BOTTLE (10702-237-01) | 100 capsule | 2018-05-17 | 0000-00-00 | No | No | Current |