Ursodiol
- Product NDC
- 0904-6890
- 11-digit product format
- 009046890
- Labeler code
- 0904
- Product ID
- 0904-6890_ca0b53eb-7518-475a-9b3e-0dec31111904
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA202540
- Marketing category
- ANDA
- Marketing start
- 2013-08-01
- 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 |
|---|
| 0904-6890-04 | Ursodiol | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 6 |
| 0904-6890-04 | Ursodiol | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6890 | URSODIOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250209_e1f6abfd-2158-4824-b53d-717fbe6de3f9.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 |
|---|
| 0904-6890-04 | 00904689004 | 30 BLISTER PACK in 1 CARTON (0904-6890-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2013-08-01 | 0000-00-00 | No | No | Current |