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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-2548
Application NumberANDA211654
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tasimelteon
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2023
FDA Product Classification
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