Lubiprostone
- Product NDC
- 0480-3479
- 11-digit product format
- 004803479
- Labeler code
- 0480
- Product ID
- 0480-3479_22f53da2-2fb9-411d-baad-fef011383f6f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lubiprostone
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA209920
- Marketing category
- ANDA
- Marketing start
- 2023-01-03
- 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 |
|---|
| 0480-3479-06 | Lubiprostone | 60 in 1 BOTTLE | CAPSULE, GELATIN COATED | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0480-3479 | LUBIPROSTONE CAPSULE, GELATIN COATED [TEVA PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230105_e17b521e-2c25-4bef-82f9-7916fa79bca4.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 |
|---|
| 0480-3479-06 | 00480347906 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-3479-06) | 2023-01-03 | 0000-00-00 | No | No | Current |