Entereg
These highlights do not include all the information needed to use ENTEREG safely and effectively. See full prescribing information for ENTEREG. ENTEREG (alvimopan) capsules, for oral use Initial U.S. Approval: 2008
Approved
Approval ID
77a67dc6-35d3-48ff-9d18-292d4d442f70
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2023
Manufacturers
FDA
Merck Sharp & Dohme LLC
DUNS: 118446553
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 Code67919-020
Application NumberNDA021775
Product Classification
M
Marketing Category
C73594
G
Generic Name
alvimopan
Product Specifications
Route of AdministrationORAL
Effective DateMay 11, 2022
FDA Product Classification
INGREDIENTS (3)
alvimopanActive
Quantity: 12 mg in 1 1
Code: 677C126AET
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT