Ursodiol
- Product NDC
- 10135-543
- 11-digit product format
- 101350543
- Labeler code
- 10135
- Product ID
- 10135-543_445ce602-e08a-4b6d-abfb-9e7f51ff711a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- ANDA079082
- Marketing category
- ANDA
- Marketing start
- 2014-10-01
- Marketing end
- 0000-00-00
- Substance
- URSODIOL
- Active strength
- 300 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 |
|---|
| 10135-543-01 | Ursodiol | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-543 | URSODIOL CAPSULE [MARLEX PHARMACEUTICALS INC] | 2 | Legacy NDC, 1 package rows | 20150326_b636694a-26af-4ed2-8b77-197e82a46de7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10135-543-01 | 10135054301 | 100 in 1 BOTTLE | Historical |