Ursodiol
- Product NDC
- 62135-430
- 11-digit product format
- 621350430
- Labeler code
- 62135
- Product ID
- 62135-430_06fd3682-9361-c825-e063-6394a90a4cb3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA213555
- Marketing category
- ANDA
- Marketing start
- 2020-08-17
- 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 |
|---|
| 62135-430-60 | Ursodiol | 60 in 1 BOTTLE | CAPSULE | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-430 | URSODIOL CAPSULE [CHARTWELL RX, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231006_31ff3961-3ef1-4ec3-b742-beb4b96de795.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 |
|---|
| 62135-430-60 | 62135043060 | 60 CAPSULE in 1 BOTTLE (62135-430-60) | 60 capsule | 2023-01-03 | 0000-00-00 | No | No | Current |