Lubiprostone
- Product NDC
- 82804-001
- 11-digit product format
- 828040001
- Labeler code
- 82804
- Product ID
- 82804-001_34c547c4-4c29-45a9-97c7-a828bf2ecde0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lubiprostone
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- NDA021908
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2023-01-01
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-001-30 | 82804000130 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-001-30) | 2023-08-24 | No | No | Historical |
| 82804-001-60 | 82804000160 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-001-60) | 2023-08-24 | No | No | Historical |
| 82804-001-90 | 82804000190 | 90 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-001-90) | 2023-08-24 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lubiprostone | Proficient Rx LP | 2023-08-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |