Ursodiol
- Product NDC
- 72162-2168
- 11-digit product format
- 721622168
- Labeler code
- 72162
- Product ID
- 72162-2168_ebdd40ad-00e7-46e8-bad8-47c8f62c98d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075517
- Marketing category
- ANDA
- Marketing start
- 2010-07-16
- 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 |
|---|
| 72162-2168-1 | Ursodiol | 100 in 1 BOTTLE | CAPSULE | 100 | | 100 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-2168 | URSODIOL CAPSULE [BRYANT RANCH PREPACK] | 100 | Current NDC, 1 package rows | 20231212_011ede7f-bb4d-45f7-8041-9feb4aa2ba7d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2168-1 | 72162216801 | 100 CAPSULE in 1 BOTTLE (72162-2168-1) | 100 capsule | 2023-12-07 | No | No | Current |