Ursodiol
- Product NDC
- 68462-473
- 11-digit product format
- 684620473
- Labeler code
- 68462
- Product ID
- 68462-473_71c17751-51cb-411d-b90b-4b98ad4a768e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA090801
- Marketing category
- ANDA
- Marketing start
- 2011-07-12
- Substance
- URSODIOL
- Active strength
- 250 mg/1
- Pharmacologic classes
- Bile Acid [EPC], Bile Acids and Salts [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ursodiol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| URSODIOL | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 724L30Y2QR |
| Rxcui | 858733, 858751 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-473-01 | Ursodiol | 100 in 1 BOTTLE | TABLET | 100 | | 13 |
| 68462-473-05 | Ursodiol | 500 in 1 BOTTLE | TABLET | 500 | | 13 |
| 68462-473-30 | Ursodiol | 30 in 1 BOTTLE | TABLET | 30 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| URSODIOL | ACTIVE INGREDIENT | 724L30Y2QR | URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| URSODIOL | ACTIVE MOIETY | 724L30Y2QR | URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| DIBUTYL SEBACATE | INACTIVE INGREDIENT | 4W5IH7FLNY | URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-473 | URSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 12 | Current NDC, Legacy NDC, 3 package rows | 20230224_fb79b62a-b450-4d7a-be28-5ee4d174fd58.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 |
|---|
| 68462-473-01 | 68462047301 | 100 TABLET in 1 BOTTLE (68462-473-01) | 100 tablet | 2011-07-12 | 0000-00-00 | No | No | Current |
| 68462-473-05 | 68462047305 | 500 TABLET in 1 BOTTLE (68462-473-05) | 500 tablet | 2011-07-12 | 0000-00-00 | No | No | Current |
| 68462-473-30 | 68462047330 | 30 TABLET in 1 BOTTLE (68462-473-30) | 30 tablet | 2011-07-12 | 0000-00-00 | No | No | Current |