Ursodiol
- Product NDC
- 49884-412
- 11-digit product format
- 498840412
- Labeler code
- 49884
- Product ID
- 49884-412_e0a305a9-0627-494f-aa1d-117c45eba561
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Endo USA, Inc.
- Application
- ANDA202540
- Marketing category
- ANDA
- Marketing start
- 2013-08-01
- Substance
- URSODIOL
- Active strength
- 250 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 | 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 |
|---|
| 49884-412-01 | Ursodiol | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 12 |
| 49884-412-05 | Ursodiol | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| URSODIOL | ACTIVE INGREDIENT | 724L30Y2QR | URSODIOL TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 4 | |
| URSODIOL | ACTIVE MOIETY | 724L30Y2QR | URSODIOL TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | URSODIOL TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 4 | |
| COPOVIDONE K25-31 | INACTIVE INGREDIENT | D9C330MD8B | URSODIOL TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | URSODIOL TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | URSODIOL TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 4 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | URSODIOL TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 4 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | URSODIOL TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 4 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | URSODIOL TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 4 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | URSODIOL TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | URSODIOL TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | URSODIOL TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-412 | URSODIOL TABLET, FILM COATED [ENDO USA, INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20241212_1a3a8942-94d4-4292-bf74-0a67d92acb90.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49884-412-01 | 49884041201 | 100 TABLET, FILM COATED in 1 BOTTLE (49884-412-01) | 2013-08-01 | 0000-00-00 | No | No | Current |
| 49884-412-05 | 49884041205 | 500 TABLET, FILM COATED in 1 BOTTLE (49884-412-05) | 2013-08-01 | 0000-00-00 | No | No | Current |