Lubiprostone
- Product NDC
- 80425-0355
- 11-digit product format
- 804250355
- Labeler code
- 80425
- Product ID
- 80425-0355_2a999573-102f-813a-e063-6294a90a49b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lubiprostone
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- NDA021908
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2023-08-16
- Substance
- LUBIPROSTONE
- Active strength
- 24 ug/1
- Pharmacologic classes
- Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lubiprostone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LUBIPROSTONE | 24 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7662KG2R6K |
| Rxcui | 616578 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0355-2 | Lubiprostone | 60 in 1 BOTTLE | CAPSULE, GELATIN COATED | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0355 | LUBIPROSTONE CAPSULE, GELATIN COATED [ADVANCED RX OF TENNESSEE, LLC] | 2 | Current NDC, 1 package rows | 20250101_031149b9-c709-de1f-e063-6394a90a6d81.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0355-2 | 80425035502 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (80425-0355-2) | 2023-08-16 | No | No | Historical |