Ursodiol
- Product NDC
- 69189-0413
- 11-digit product format
- 691890413
- Labeler code
- 69189
- Product ID
- 69189-0413_6e1ee8b0-ead5-44fb-9c65-baf5b1f3a514
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Avera McKennan Hospital
- Application
- ANDA202540
- Marketing category
- ANDA
- Marketing start
- 2015-08-18
- Marketing end
- 0000-00-00
- Substance
- URSODIOL
- Active strength
- 250 mg/1
- Pharmacologic classes
- Bile Acid [EPC],Bile Acids and Salts [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69189-0413-1 | Ursodiol | 1 in 1 DOSE PACK | TABLET, FILM COATED | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69189-0413 | URSODIOL TABLET, FILM COATED [AVERA MCKENNAN HOSPITAL] | 1 | Legacy NDC, 1 package rows | 20151222_56eb5083-38b8-4b09-9e42-fb363ca70809.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 69189-0413-1 | 69189041301 | 1 in 1 DOSE PACK | Historical |