Ursodiol
- Product NDC
- 72603-613
- 11-digit product format
- 726030613
- Labeler code
- 72603
- Product ID
- 72603-613_b762c96f-bb2e-4268-b71c-ccda296cb299
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA214849
- Marketing category
- ANDA
- Marketing start
- 2025-05-01
- Substance
- URSODIOL
- Active strength
- 300 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 | 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 |
|---|
| 72603-613-01 | Ursodiol | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-613 | URSODIOL CAPSULE [NORTHSTAR RX LLC] | 1 | Current NDC, 1 package rows | 20250501_dd0346e2-5ff3-4208-ad88-d09182684603.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-613-01 | 72603061301 | 100 CAPSULE in 1 BOTTLE (72603-613-01) | 100 capsule | 2025-05-01 | No | No | Current |