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
e17b521e-2c25-4bef-82f9-7916fa79bca4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 27, 2022
Manufacturers
FDA
Teva Pharmaceuticals, Inc.
DUNS: 022629579
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 Code0480-4138
Application NumberANDA209920
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lubiprostone
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2022
FDA Product Classification
INGREDIENTS (11)
LUBIPROSTONEActive
Quantity: 24 ug in 1 1
Code: 7662KG2R6K
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
Lubiprostone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0480-3479
Application NumberANDA209920
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lubiprostone
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2022
FDA Product Classification
INGREDIENTS (11)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LUBIPROSTONEActive
Quantity: 8 ug in 1 1
Code: 7662KG2R6K
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT