Tasimelteon
These highlights do not include all the information needed to use TASIMELTEON CAPSULES safely and effectively. See full prescribing information for TASIMELTEON CAPSULES. TASIMELTEON capsules, for oral use Initial U.S. Approval: 2014
Approved
Approval ID
46b09064-a675-92d5-24a7-dac0410f77ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2024
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
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 Code60505-4665
Application NumberANDA211607
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tasimelteon
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2024
FDA Product Classification
INGREDIENTS (14)
ShellacInactive
Code: 46N107B71O
Classification: IACT
Fd&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
TasimelteonActive
Quantity: 20 mg in 1 1
Code: SHS4PU80D9
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Fd&C Red No. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
Fd&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT