Lubiprostone
- Product NDC
- 70771-1763
- 11-digit product format
- 707711763
- Labeler code
- 70771
- Product ID
- 70771-1763_570c527a-5ee5-4950-b27a-48f652af549f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lubiprostone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70771-1763-1 | Lubiprostone | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
| 70771-1763-6 | Lubiprostone | 60 in 1 BOTTLE | CAPSULE | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1763 | LUBIPROSTONE CAPSULE [ZYDUS LIFESCIENCES LIMITED] | 2 | Current NDC, 2 package rows | 20241204_81f9c9de-f89d-4ab0-a8ca-18d3691e42f9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1763-1 | 70771176301 | 100 CAPSULE in 1 BOTTLE (70771-1763-1) | 100 capsule | 2023-03-23 | No | No | Historical |
| 70771-1763-6 | 70771176306 | 60 CAPSULE in 1 BOTTLE (70771-1763-6) | 60 capsule | 2023-03-23 | No | No | Historical |