Reltone 400 mg
- Product NDC
- 80056-144
- 11-digit product format
- 800560144
- Labeler code
- 80056
- Product ID
- 80056-144_1fc18c67-20db-4fe5-bc22-2772f0788d13
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ursodiol
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Intra-Sana Laboratories
- Application
- ANDA205789
- Marketing category
- ANDA
- Marketing start
- 2020-07-01
- Substance
- URSODIOL
- Active strength
- 400 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
- Reltone 400 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| URSODIOL | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 724L30Y2QR |
| Rxcui | 412174, 2376942, 2477896, 2477898 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80056-144-01 | Reltone 400 mg | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80056-144 | RELTONE 200 MG (URSODIOL) CAPSULE RELTONE 400 MG (URSODIOL) CAPSULE [INTRA-SANA LABORATORIES] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230117_d1c28b0b-8f3c-4d60-8182-24a4c659d762.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 |
|---|
| 80056-144-01 | 80056014401 | 100 CAPSULE in 1 BOTTLE (80056-144-01) | 100 capsule | 2021-02-15 | 0000-00-00 | No | No | Current |