LUBIPROSTONE
- Product NDC
- 69339-162
- 11-digit product format
- 693390162
- Labeler code
- 69339
- Product ID
- 69339-162_8eaefb22-646d-468c-9b62-a1c8585440e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LUBIPROSTONE
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Natco Pharma USA LLC
- Application
- NDA021908
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2022-10-17
- 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 |
|---|
| 69339-162-17 | LUBIPROSTONE | 40 in 1 CARTON | CAPSULE, GELATIN COATED | 40 | | 8 |
| 69339-162-98 | LUBIPROSTONE | 1 in 1 BLISTER PACK | CAPSULE, GELATIN COATED | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69339-162 | LUBIPROSTONE CAPSULE [NATCO PHARMA USA LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250112_10c7b62d-6c39-453c-8d9a-2f441725bc3b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69339-162-17 | 69339016217 | 40 BLISTER PACK in 1 CARTON (69339-162-17) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (69339-162-98) | 40 blister pack | 2022-10-17 | | No | No | Historical |
| 69339-162-98 | 69339016298 | 40 BLISTER PACK in 1 CARTON (69339-162-98) > 10 CAPSULE in 1 BLISTER PACK | 40 blister pack | 2022-10-17 | 0000-00-00 | No | No | Current |