Alvimopan
These highlights do not include all the information needed to use ALVIMOPAN CAPSULES safely and effectively. See full prescribing information for ALVIMOPAN CAPSULES. ALVIMOPAN capsules, for oral use Initial U.S. Approval: 2008
Approved
Approval ID
2a0645b4-daf8-421f-b987-a4e478843c5d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2021
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Alvimopan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-2312
Application NumberANDA208295
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alvimopan
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2021
FDA Product Classification
INGREDIENTS (10)
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ALVIMOPANActive
Quantity: 12 mg in 1 1
Code: 677C126AET
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT