Lubiprostone
- Product NDC
- 70710-1642
- 11-digit product format
- 707101642
- Labeler code
- 70710
- Product ID
- 70710-1642_f06e99fa-9894-48ab-99d8-914987dbb73f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lubiprostone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals 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 |
|---|
| 70710-1642-1 | 70710164201 | 100 CAPSULE in 1 BOTTLE (70710-1642-1) | 100 capsule | 2023-03-23 | No | No | Historical |
| 70710-1642-6 | 70710164206 | 60 CAPSULE in 1 BOTTLE (70710-1642-6) | 60 capsule | 2023-03-23 | 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 |
| Lubiprostone | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2023-03-27 | HUMAN PRESCRIPTION DRUG LABEL | 1 |