Amitiza
These highlights do not include all the information needed to use AMITIZA safely and effectively. See full prescribing information for AMITIZA. AMITIZA (lubiprostone) capsule, gelatin coated for oral use Initial U.S. Approval: 2006
Approved
Approval ID
417aa15d-ac74-4fa8-a312-6e51e82ba70c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 25, 2019
Manufacturers
FDA
Lake Erie Medical DBA Quality Care Products LLC
DUNS: 831276758
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lubiprostone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35356-500
Application NumberNDA021908
Product Classification
M
Marketing Category
C73594
G
Generic Name
lubiprostone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2018
FDA Product Classification
INGREDIENTS (7)
lubiprostoneActive
Quantity: 24 ug in 1 1
Code: 7662KG2R6K
Classification: ACTIB
sorbitolInactive
Code: 506T60A25R
Classification: IACT
medium-chain triglyceridesInactive
Code: C9H2L21V7U
Classification: IACT
FD&C red no. 40Inactive
Code: WZB9127XOA
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
D&C yellow no. 10Inactive
Code: 35SW5USQ3G
Classification: IACT