SYMPROIC
These highlights do not include all the information needed to use SYMPROIC safely and effectively. See full prescribing information for SYMPROIC. SYMPROIC (naldemedine tablets for oral use) Initial U.S. Approval: 2017
Approved
Approval ID
b1a1256c-a1eb-4abe-ab1e-30e4711afd16
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2022
Manufacturers
FDA
BioDelivery Sciences International Inc
DUNS: 016058955
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
naldemedine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59385-041
Application NumberNDA208854
Product Classification
M
Marketing Category
C73594
G
Generic Name
naldemedine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 30, 2021
FDA Product Classification
INGREDIENTS (7)
naldemedine tosylateActive
Quantity: 0.2 mg in 1 1
Code: V1N8F1RVVO
Classification: ACTIM
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT