Lubiprostone
- Product NDC
- 83008-001
- 11-digit product format
- 830080001
- Labeler code
- 83008
- Product ID
- 83008-001_fd3c99bd-7841-472f-bb74-abe1dc15ee8a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lubiprostone
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- NDA021908
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2023-03-14
- Marketing end
- 2026-08-31
- Substance
- LUBIPROSTONE
- Active strength
- 24 ug/1
- Pharmacologic classes
- Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lubiprostone
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LUBIPROSTONE | 24 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7662KG2R6K |
| Rxcui | 616578 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83008-001-60 | 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 |
|---|
| 83008-001 | LUBIPROSTONE CAPSULE, GELATIN COATED [QUALITY CARE PRODUCTS, LLC] | 3 | Current NDC, 1 package rows | 20241222_9bffe7c4-40f2-4490-a32f-15d525000928.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 83008-001-60 | 83008000160 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (83008-001-60) | 2023-03-14 | 2026-08-31 | No | No | Historical |