Ursodiol
- Product NDC
- 60687-100
- 11-digit product format
- 606870100
- Labeler code
- 60687
- Product ID
- 60687-100_37f083e8-2223-360b-e063-6294a90aa549
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA079082
- Marketing category
- ANDA
- Marketing start
- 2015-05-12
- 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 |
|---|
| 60687-100-01 | Ursodiol | 100 in 1 BOX, UNIT-DOSE | CAPSULE | 100 | | 10 |
| 60687-100-11 | Ursodiol | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-100 | URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241115_9ae9412b-36d5-4634-8d5c-cc96110821c0.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 |
|---|
| 60687-100-01 | 60687010001 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-100-01) / 1 CAPSULE in 1 BLISTER PACK (60687-100-11) | 100 blister pack | 2015-05-12 | 0000-00-00 | No | No | Current |
| 60687-100-11 | 60687010011 | 1 in 1 BLISTER PACK | | | | | | Historical |