amitiza
Generic: lubiprostone
Labeler: takeda pharmaceuticals america, inc.Drug Facts
Product Profile
Brand Name
amitiza
Generic Name
lubiprostone
Labeler
takeda pharmaceuticals america, inc.
Dosage Form
CAPSULE, GELATIN COATED
Routes
Active Ingredients
lubiprostone 8 ug/1
Manufacturer
Identifiers & Regulatory
Product NDC
64764-080
Product ID
64764-080_c2ca8178-4da1-42d1-a8b9-ff66dca82649
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
NDA
Application Number
NDA021908
Marketing Start
2006-01-31
Marketing End
2027-03-31
Pharmacologic Class
Established (EPC)
Mechanism of Action
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
64764080
Hyphenated Format
64764-080
Supplemental Identifiers
RxCUI
UNII
NUI
Packaging Origin
Original Packager
Resolved Product View
Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.
Resolved Identity
Brand Name
amitiza (source: ndc)
Generic Name
lubiprostone (source: ndc)
Application Number
NDA021908 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 8 ug/1
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING Amitiza is available as an oval, soft gelatin capsule containing 8 mcg or 24 mcg of lubiprostone with "SPI" printed on one side. Amitiza is available as follows: 8 mcg pink capsule Bottles of 60 (NDC 64764-080-60) 24 mcg orange capsule Bottles of 60 (NDC 64764-240-60) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light and extreme temperatures.
- PRINCIPAL DISPLAY PANEL - 8 mcg Capsule Bottle Label Rx Only 60 Capsules AMITIZA ® (lubiprostone) capsules 8 mcg NDC 64764-080-60 SUCAMPO Takeda See package insert for complete prescribing information. Keep out of reach of children. Marketed by: Sucampo Pharma Americas LLC, Bedminster, NJ 07921 and Takeda Pharmaceuticals America, Inc., Lexington, MA 02421. Active ingredient made in Japan; encapsulated in the United States. PRINCIPAL DISPLAY PANEL - 8 mcg Capsule Bottle Label
- PRINCIPAL DISPLAY PANEL - 24 mcg Capsule Bottle Label Rx Only 60 Capsules AMITIZA ® (lubiprostone) capsules 24 mcg NDC 64764-240-60 SUCAMPO Takeda See package insert for complete prescribing information. Keep out of reach of children. Marketed by: Sucampo Pharma Americas, LLC, Bedminster, NJ 07921 and Takeda Pharmaceuticals America, Inc., Lexington, MA 02421. Active ingredient made in Japan; encapsulated in the United States. PRINCIPAL DISPLAY PANEL - 24 mcg Capsule Bottle Label
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
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