Amitiza 8 ug/1
lubiprostone · CAPSULE, GELATIN COATED · SpecGx LLC
Amitiza is a capsule, gelatin coated containing lubiprostone at 8 ug/1, taken oral. Manufactured by SpecGx LLC.
Key Facts
- Brand Name
- Amitiza
- Generic Name
- lubiprostone
- NDC Code (Product)
23635-508- Manufacturer
- SpecGx LLC
- Strength
- 8 ug/1
- Dosage Form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA021908
- Drug Class
- Chloride Channel Activator [EPC]
- Marketing Start
- 04/01/2024
Recall History
MALLINCKRODT PHARMACEUTICALS
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Takeda Development Center Americas, Inc.
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
MALLINCKRODT PHARMACEUTICALS
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Frequently Asked Questions
What is Amitiza used for?
Amitiza contains lubiprostone. It is a capsule, gelatin coated taken oral. Consult your doctor for specific uses.
Is Amitiza a controlled substance?
Amitiza is not classified as a controlled substance by the DEA.
What is the generic name for Amitiza?
The generic name for Amitiza is lubiprostone. There are 10 other brand versions of lubiprostone.
What is the NDC code for Amitiza 8 ug/1?
The NDC (National Drug Code) for Amitiza 8 ug/1 is 23635-508, listed by SpecGx LLC.