Amitiza
- Product NDC
- 35356-500
- 11-digit product format
- 353560500
- Labeler code
- 35356
- Product ID
- 35356-500_baf8d3dc-b57f-4bcf-8a75-70ccd3f4e03d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lubiprostone
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- NDA021908
- Marketing category
- NDA
- Marketing start
- 2011-06-01
- Marketing end
- 0000-00-00
- Substance
- LUBIPROSTONE
- Active strength
- 24 ug/1
- Pharmacologic classes
- Chloride Channel Activator [EPC],Chloride Channel Activators [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 35356-500-60 | 35356050060 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (35356-500-60) | 2011-06-01 | 0000-00-00 | No | No | Current |