Lubiprostone
- Product NDC
- 0254-3028
- 11-digit product format
- 002543028
- Labeler code
- 0254
- Product ID
- 0254-3028_b2963600-7298-4a60-9e74-11a25cb5b67d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lubiprostone
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- NDA021908
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2021-01-01
- Substance
- LUBIPROSTONE
- Active strength
- 8 ug/1
- Pharmacologic classes
- Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lubiprostone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LUBIPROSTONE | 8 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7662KG2R6K |
| Rxcui | 616578, 794639 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0254-3028-02 | Lubiprostone | 60 in 1 BOTTLE | CAPSULE, GELATIN COATED | 60 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0254-3028 | LUBIPROSTONE CAPSULE, GELATIN COATED [ENDO USA, INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20250322_9d958b58-6c4f-4bb1-8660-cf5eac256440.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 |
|---|
| 0254-3028-02 | 00254302802 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0254-3028-02) | 2021-01-01 | 0000-00-00 | No | No | Current |