Ursodiol
- Product NDC
- 68151-2987
- 11-digit product format
- 681512987
- Labeler code
- 68151
- Product ID
- 68151-2987_cf8b8ae8-c813-4c3d-9360-f908016c89f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Carilion Materials Management
- Application
- NDA019594
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 1987-12-31
- 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
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1ab35ce6-695f-4d1d-43b4-c16fd63c1674 | Product name | 3 | 20250317 |
| 74e0d644-a165-40ec-b881-1b01c8aa68a4 | Product name | 1 | 20201006 |
| 24881a03-c677-697f-03b9-66e93689fade | Product name | 2 | 20180724 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68151-2987-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1ff6-f424-e053-dadaa90a57ce | Ursodiol Capsules USP Content Updated: November 2014 Rx only 174784 -2 Prescribing Information |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-2987-0 | Ursodiol | 1 in 1 PACKAGE | CAPSULE | 1 | 3 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| URSODIOL | ACTIVE INGREDIENT | 724L30Y2QR | URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | |
| URSODIOL | ACTIVE MOIETY | 724L30Y2QR | URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-2987 | URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] | 3 | Legacy NDC, 1 package rows | 20160805_74c157f6-c95d-410e-91af-5c38849286c4.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 858747 | ursodiol 300 MG Oral Capsule | PSN | 74c157f6-c95d-410e-91af-5c38849286c4 | 3 |
| 858747 | ursodiol 300 MG Oral Capsule | SCD | 74c157f6-c95d-410e-91af-5c38849286c4 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68151-2987-0 | 68151298700 | 1 in 1 PACKAGE | Historical |