Lubiprostone
- Product NDC
- 76420-778
- 11-digit product format
- 764200778
- Labeler code
- 76420
- Product ID
- 76420-778_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
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 7662KG2R6K | LUBIPROSTONE | 136790-76-6 | LUBIPROSTONE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-778-01 | 76420077801 | 100 CAPSULE in 1 BOTTLE (76420-778-01) | 100 capsule | 2025-02-07 | No | No | Historical |
| 76420-778-30 | 76420077830 | 30 CAPSULE in 1 BOTTLE (76420-778-30) | 30 capsule | 2025-02-07 | No | No | Historical |
| 76420-778-60 | 76420077860 | 60 CAPSULE in 1 BOTTLE (76420-778-60) | 60 capsule | 2025-02-07 | No | No | Historical |
| 76420-778-90 | 76420077890 | 90 CAPSULE in 1 BOTTLE (76420-778-90) | 90 capsule | 2025-02-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lubiprostone | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2025-02-06 | HUMAN PRESCRIPTION DRUG LABEL | 1 |