NDC 64764-240 – Amitiza
Lubiprostone 24 ug/1 · Capsule, Gelatin Coated · Oral
Product NDC64764-240
Product details
- Brand name
- Amitiza
- Generic name
- Lubiprostone
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Dosage form
- Capsule, Gelatin Coated
- Route
- Oral
- Marketing category
- NDA · NDA021908
- Marketed since
- January 31, 2006
- Marketing end
- March 31, 2027
- Pharmacologic class
- Chloride Channel Activator
Active ingredients
- Lubiprostone 24 ug/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 64764-240-60 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64764-240-60) | Jan 31, 2006 |
Recalls mentioning this NDC
- D-1295-2019 May 29, 2019 · Class II
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.… - D-1294-2019 May 29, 2019 · Class II
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.… - D-0286-2019 Nov 21, 2018 · Class III
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.