Ursodiol
- Product NDC
- 60687-527
- 11-digit product format
- 606870527
- Labeler code
- 60687
- Product ID
- 60687-527_437ecc8a-2e45-94a1-e063-6394a90acc85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA211145
- Marketing category
- ANDA
- Marketing start
- 2020-09-11
- Substance
- URSODIOL
- Active strength
- 250 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 | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 724L30Y2QR |
| Rxcui | 858751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-527-11 | Ursodiol | 1 in 1 BLISTER PACK | TABLET | 1 | | 4 |
| 60687-527-21 | Ursodiol | 30 in 1 BOX, UNIT-DOSE | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-527 | URSODIOL TABLET [AMERICAN HEALTH PACKAGING] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240415_a3a90d07-0dac-48fc-829a-759d9333843e.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 |
|---|
| 60687-527-11 | 60687052711 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 60687-527-21 | 60687052721 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-527-21) / 1 TABLET in 1 BLISTER PACK (60687-527-11) | 30 blister pack | 2020-09-11 | 0000-00-00 | No | No | Current |