Lubiprostone
- Product NDC
- 76420-777
- 11-digit product format
- 764200777
- Labeler code
- 76420
- Product ID
- 76420-777_2d872107-0284-f85f-e063-6394a90a6258
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lubiprostone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA214131
- Marketing category
- ANDA
- Marketing start
- 2023-03-23
- Substance
- LUBIPROSTONE
- Active strength
- 8 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 | 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 |
|---|
| 76420-777-01 | Lubiprostone | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 76420-777-30 | Lubiprostone | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 76420-777-60 | Lubiprostone | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
| 76420-777-90 | Lubiprostone | 90 in 1 BOTTLE | CAPSULE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-777 | LUBIPROSTONE CAPSULE [ASCLEMED USA, INC.] | 1 | Current NDC, 4 package rows | 20250210_5797e57c-4e87-48d9-b16d-992f64db594f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-777-01 | 76420077701 | 100 CAPSULE in 1 BOTTLE (76420-777-01) | 100 capsule | 2025-02-07 | No | No | Current |
| 76420-777-30 | 76420077730 | 30 CAPSULE in 1 BOTTLE (76420-777-30) | 30 capsule | 2025-02-07 | No | No | Current |
| 76420-777-60 | 76420077760 | 60 CAPSULE in 1 BOTTLE (76420-777-60) | 60 capsule | 2025-02-07 | No | No | Current |
| 76420-777-90 | 76420077790 | 90 CAPSULE in 1 BOTTLE (76420-777-90) | 90 capsule | 2025-02-07 | No | No | Current |