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 useInitial U.S. Approval: 2006
Approved
Approval ID
6c11a204-6831-4269-a3c4-1702ed83f74b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 27, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
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 Code70710-1642
Application NumberANDA214131
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lubiprostone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2023
FDA Product Classification
INGREDIENTS (9)
LUBIPROSTONEActive
Quantity: 24 ug in 1 1
Code: 7662KG2R6K
Classification: ACTIB
1,4-SORBITANInactive
Code: AV0YTZ4E6J
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Lubiprostone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1641
Application NumberANDA214131
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lubiprostone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2023
FDA Product Classification
INGREDIENTS (11)
LUBIPROSTONEActive
Quantity: 8 ug in 1 1
Code: 7662KG2R6K
Classification: ACTIB
1,4-SORBITANInactive
Code: AV0YTZ4E6J
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT