URSODIOL
- Product NDC
- 64380-844
- 11-digit product format
- 643800844
- Labeler code
- 64380
- Product ID
- 64380-844_46e8718f-fb37-4590-ad7e-7a55913fddf4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA210344
- Marketing category
- ANDA
- Marketing start
- 2021-09-13
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-844-04 | URSODIOL | 30 in 1 BOTTLE | CAPSULE | 30 | | 9 |
| 64380-844-06 | URSODIOL | 100 in 1 BOTTLE | CAPSULE | 100 | | 9 |
| 64380-844-07 | URSODIOL | 500 in 1 BOTTLE | CAPSULE | 500 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-844 | URSODIOL CAPSULE [STRIDES PHARMA SCIENCE LIMITED] | 9 | Current NDC, Legacy NDC, 3 package rows | 20230819_9a6c1928-2d52-4d9a-8e83-f71892a7e98d.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 |
|---|
| 64380-844-04 | 64380084404 | 30 CAPSULE in 1 BOTTLE (64380-844-04) | 30 capsule | 2021-09-13 | 0000-00-00 | No | No | Current |
| 64380-844-06 | 64380084406 | 100 CAPSULE in 1 BOTTLE (64380-844-06) | 100 capsule | 2021-09-13 | 0000-00-00 | No | No | Current |
| 64380-844-07 | 64380084407 | 500 CAPSULE in 1 BOTTLE (64380-844-07) | 500 capsule | 2021-09-13 | 0000-00-00 | No | No | Current |