Amitiza
- Product NDC
- 23635-508
- 11-digit product format
- 236350508
- Labeler code
- 23635
- Product ID
- 23635-508_8b815df4-ea84-46ca-9f53-fe89011d259e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lubiprostone
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- NDA021908
- Marketing category
- NDA
- Marketing start
- 2024-04-01
- 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
- Amitiza
- 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, 617768, 794639, 794641 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 23635-508-60 | Amitiza | 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 |
|---|
| 23635-508 | AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [SPECGX LLC] | 2 | Current NDC, 1 package rows | 20250316_164a2b47-0a52-4bb4-9e71-5342c2e951f4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 23635-508-60 | 23635050860 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (23635-508-60) | 2024-04-01 | No | No | Current |