Lubiprostone
- Product NDC
- 70710-1641
- 11-digit product format
- 707101641
- Labeler code
- 70710
- Product ID
- 70710-1641_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
- 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 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70710-1641-1 | 70710164101 | 100 CAPSULE in 1 BOTTLE (70710-1641-1) | 100 capsule | 2023-03-23 | No | No | Historical |
| 70710-1641-6 | 70710164106 | 60 CAPSULE in 1 BOTTLE (70710-1641-6) | 60 capsule | 2023-03-23 | No | No | Historical |