Lubiprostone
- Product NDC
- 31722-404
- 11-digit product format
- 317220404
- Labeler code
- 31722
- Product ID
- 31722-404_5008a4ec-08c5-4d06-bac9-e7239620a07d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lubiprostone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA218640
- Marketing category
- ANDA
- Marketing start
- 2025-05-27
- Substance
- LUBIPROSTONE
- Active strength
- .024 mg/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 | .024 mg/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 |
|---|
| 31722-404-60 | Lubiprostone | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-404 | LUBIPROSTONE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20250528_6d973d7d-a43e-4495-b618-a8ad3142683d.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 |
|---|
| 31722-404-60 | 31722040460 | 60 CAPSULE in 1 BOTTLE (31722-404-60) | 60 capsule | 2025-05-27 | No | No | Current |