Ursodiol
- Product NDC
- 42806-503
- 11-digit product format
- 428060503
- Labeler code
- 42806
- Product ID
- 42806-503_392c277e-5bc5-46c7-b2f2-8b48baaa6f83
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA075517
- Marketing category
- ANDA
- Marketing start
- 2010-07-16
- 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 |
|---|
| 42806-503-01 | Ursodiol | 100 in 1 BOTTLE | CAPSULE | 100 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| URSODIOL | ACTIVE INGREDIENT | 724L30Y2QR | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 9 | |
| URSODIOL | ACTIVE MOIETY | 724L30Y2QR | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 9 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 9 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 9 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 9 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 9 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 9 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 9 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 9 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 9 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 9 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 9 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 9 | |
| URSODIOL | ACTIVE INGREDIENT | 724L30Y2QR | URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] | 2 | |
| URSODIOL | ACTIVE MOIETY | 724L30Y2QR | URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] | 2 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | URSODIOL CAPSULE [MAJOR PHARMACEUTICALS] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-503 | URSODIOL CAPSULE [EPIC PHARMA, LLC] | 17 | Current NDC, Legacy NDC, 1 package rows | 20241222_e47b49ca-bde9-448a-bf61-f943c2aa5b8e.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 |
|---|
| 42806-503-01 | 42806050301 | 100 CAPSULE in 1 BOTTLE (42806-503-01) | 100 capsule | 2010-07-16 | 0000-00-00 | No | No | Current |