Ursodiol
- Product NDC
- 42385-946
- 11-digit product format
- 423850946
- Labeler code
- 42385
- Product ID
- 42385-946_1e5a692a-cb69-4f27-b330-f4ab3cf363c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA213200
- Marketing category
- ANDA
- Marketing start
- 2021-04-17
- 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 |
|---|
| 42385-946-01 | Ursodiol | 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 |
|---|
| 42385-946 | URSODIOL CAPSULE [LAURUS LABS LIMITED] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240407_6be8e383-37fa-4e0a-b9fc-3976a8be1d2f.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 |
|---|
| 42385-946-01 | 42385094601 | 100 CAPSULE in 1 BOTTLE (42385-946-01) | 100 capsule | 2021-04-17 | 0000-00-00 | No | No | Current |