Lubiprostone
- Product NDC
- 60687-816
- 11-digit product format
- 606870816
- Labeler code
- 60687
- Product ID
- 60687-816_4dc7a17c-dac7-1755-e063-6294a90aa2e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lubiprostone
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA209920
- Marketing category
- ANDA
- Marketing start
- 2026-03-18
- Substance
- LUBIPROSTONE
- Active strength
- 8 ug/1
- Pharmacologic classes
- Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lubiprostone
- Listing expiration
- 2027-12-31
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 |
|---|
| 60687-816-32 | Lubiprostone | 20 in 1 CARTON | CAPSULE, GELATIN COATED | 20 | | 4 |
| 60687-816-33 | Lubiprostone | 1 in 1 BLISTER PACK | CAPSULE, GELATIN COATED | 1 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60687-816-32 | 60687081632 | 20 BLISTER PACK in 1 CARTON (60687-816-32) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (60687-816-33) | 20 blister pack | 2026-03-18 | No | No | Historical |
| 60687-816-33 | 60687081633 | 1 in 1 BLISTER PACK | | | | | Historical |