Tembexa
These highlights do not include all the information needed to use TEMBEXA safely and effectively. See full prescribing information for TEMBEXA. TEMBEXA (brincidofovir) tablets, for oral useTEMBEXA (brincidofovir) oral suspensionInitial U.S. Approval: 1996
Approved
Approval ID
31d6fa29-791e-4988-8758-e7e4d5b6a352
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2022
Manufacturers
FDA
Chimerix, Inc.
DUNS: 121785997
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Brincidofovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code79622-010
Application NumberNDA214461
Product Classification
M
Marketing Category
C73594
G
Generic Name
Brincidofovir
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2022
FDA Product Classification
INGREDIENTS (13)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BRINCIDOFOVIRActive
Quantity: 100 mg in 1 1
Code: 6794O900AX
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT