Amitza
Lubiprostone
Approved
Approval ID
f2121338-9586-161d-e053-2995a90af908
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2023
Manufacturers
FDA
Direct_Rx
DUNS: 079254320
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 Code72189-410
Application NumberANDA209920
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lubiprostone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2023
FDA Product Classification
INGREDIENTS (11)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LUBIPROSTONEActive
Quantity: 8 ug in 1 1
Code: 7662KG2R6K
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT