Lubiprostone
- Product NDC
- 0406-6408
- 11-digit product format
- 004066408
- Labeler code
- 0406
- Product ID
- 0406-6408_47c44abf-bfc1-49c3-96e0-91a508327d5a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lubiprostone
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- NDA021908
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2024-05-01
- 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
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 |
|---|
| 0406-6408-60 | Lubiprostone | 60 in 1 BOTTLE | CAPSULE, GELATIN COATED | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0406-6408 | LUBIPROSTONE CAPSULE, GELATIN COATED [SPECGX LLC] | 2 | Current NDC, 1 package rows | 20250322_cdf79a5a-6857-4a32-8c54-8c435d1a7535.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0406-6408-60 | 00406640860 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0406-6408-60) | 2024-05-01 | No | No | Historical |