URSODIOL
- Product NDC
- 64380-919
- 11-digit product format
- 643800919
- Labeler code
- 64380
- Product ID
- 64380-919_a9f0b231-1cf0-4695-b76c-111dfbe23d39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ursodiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA213504
- Marketing category
- ANDA
- Marketing start
- 2021-02-08
- Substance
- URSODIOL
- Active strength
- 500 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
- 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, 858751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-919-06 | URSODIOL | 100 in 1 BOTTLE | TABLET | 100 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-919 | URSODIOL TABLET [STRIDES PHARMA SCIENCE LIMITED] | 10 | Current NDC, Legacy NDC, 1 package rows | 20250316_9d666bbc-98c4-445f-a5a2-cad1bcccde4e.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 |
|---|
| 64380-919-06 | 64380091906 | 100 TABLET in 1 BOTTLE (64380-919-06) | 100 tablet | 2021-02-08 | 0000-00-00 | No | No | Current |