Lubiprostone
- Product NDC
- 76420-906
- 11-digit product format
- 764200906
- Labeler code
- 76420
- Product ID
- 76420-906_2cbe759e-e896-7ada-e063-6394a90a6cc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lubiprostone
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- NDA021908
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2023-01-01
- 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
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 |
|---|
| 76420-906-01 | 76420090601 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-01) | 2025-01-28 | No | No | Historical |
| 76420-906-30 | 76420090630 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-30) | 2025-01-28 | No | No | Historical |
| 76420-906-60 | 76420090660 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-60) | 2025-01-28 | No | No | Historical |
| 76420-906-90 | 76420090690 | 90 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-906-90) | 2025-01-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lubiprostone | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2025-01-28 | HUMAN PRESCRIPTION DRUG LABEL | 1 |