Ursodiol
- Product NDC
- 72789-205
- 11-digit product format
- 727890205
- Labeler code
- 72789
- Product ID
- 72789-205_e6618418-a511-30c2-e053-2a95a90a124a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA212452
- Marketing category
- ANDA
- Marketing start
- 2020-02-05
- 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
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-205 | URSODIOL CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 5 | Legacy NDC | 20240217_1276283e-21b0-4932-864f-547c62bd49e5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72789-205-01 | 72789020501 | 100 CAPSULE in 1 BOTTLE, PLASTIC (72789-205-01) | 100 capsule | 2021-10-11 | 0000-00-00 | No | No | Current |