Lubiprostone
These highlights do not include all the information needed to use LUBIPROSTONE CAPSULES safely and effectively. See full prescribing information for LUBIPROSTONE CAPSULES. LUBIPROSTONE capsules, for oral use Initial U.S. Approval: 2006
Approved
Approval ID
9d958b58-6c4f-4bb1-8660-cf5eac256440
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 13, 2021
Manufacturers
FDA
Par Pharmaceutical Inc.
DUNS: 092733690
Products 2
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 Code0254-3028
Application NumberNDA021908
Product Classification
M
Marketing Category
C73605
G
Generic Name
Lubiprostone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2020
FDA Product Classification
INGREDIENTS (7)
lubiprostoneActive
Quantity: 8 ug in 1 1
Code: 7662KG2R6K
Classification: ACTIB
medium-chain triglyceridesInactive
Code: C9H2L21V7U
Classification: IACT
gelatin, unspecifiedInactive
Code: 2G86QN327L
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sorbitolInactive
Code: 506T60A25R
Classification: IACT
Lubiprostone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0254-3029
Application NumberNDA021908
Product Classification
M
Marketing Category
C73605
G
Generic Name
Lubiprostone
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2020
FDA Product Classification
INGREDIENTS (7)
medium-chain triglyceridesInactive
Code: C9H2L21V7U
Classification: IACT
gelatin, unspecifiedInactive
Code: 2G86QN327L
Classification: IACT
FD&C red no. 40Inactive
Code: WZB9127XOA
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
lubiprostoneActive
Quantity: 24 ug in 1 1
Code: 7662KG2R6K
Classification: ACTIB
sorbitolInactive
Code: 506T60A25R
Classification: IACT
D&C yellow no. 10Inactive
Code: 35SW5USQ3G
Classification: IACT