Tasimelteon
TASIMELTEON capsules, for oral use
Approved
Approval ID
99cb1928-e57d-4d04-87a1-38108780598a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tasimelteon
PRODUCT DETAILS
NDC Product Code69238-2548
Application NumberANDA211654
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 24, 2023
Generic NameTasimelteon
INGREDIENTS (9)
TASIMELTEONActive
Quantity: 20 mg in 1 1
Code: SHS4PU80D9
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT