Ursodiol
- Product NDC
- 50268-797
- 11-digit product format
- 502680797
- Labeler code
- 50268
- Product ID
- 50268-797_48378beb-66aa-975e-e063-6294a90a0aee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA211301
- Marketing category
- ANDA
- Marketing start
- 2021-02-19
- Substance
- URSODIOL
- Active strength
- 300 mg/1
- Pharmacologic classes
- Bile Acid [EPC], Bile Acids and Salts [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ursodiol
- Listing expiration
- 2027-12-31
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 |
|---|
| 50268-797-11 | Ursodiol | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 4 |
| 50268-797-15 | Ursodiol | 50 in 1 BOX | CAPSULE | 50 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-797 | URSODIOL CAPSULE [AVPAK] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240110_bbb1f297-1536-9550-e053-2995a90a0d41.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 |
|---|
| 50268-797-11 | 50268079711 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-797-15 | 50268079715 | 50 BLISTER PACK in 1 BOX (50268-797-15) / 1 CAPSULE in 1 BLISTER PACK (50268-797-11) | 50 blister pack | 2021-02-19 | 0000-00-00 | No | No | Current |