ALVIMOPAN
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . ALVIMOPAN capsules, for oral use Initial U.S. Approval: 2008
Approved
Approval ID
1cd584de-b704-4d26-8451-e3247ffb8d08
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 26, 2023
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
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 Code0254-3012
Application NumberANDA216843
Product Classification
M
Marketing Category
C73584
G
Generic Name
ALVIMOPAN
Product Specifications
Route of AdministrationORAL
Effective DateApril 26, 2023
FDA Product Classification
INGREDIENTS (11)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALVIMOPANActive
Quantity: 12 mg in 1 1
Code: 677C126AET
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT