Trecator
Trecator (ethionamide tablets, USP) Tablets
Approved
Approval ID
04a413fe-95f4-47a7-42ac-283a9e78297d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2023
Manufacturers
FDA
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
DUNS: 113008515
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ethionamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0008-4117
Application NumberNDA013026
Product Classification
M
Marketing Category
C73594
G
Generic Name
ethionamide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2023
FDA Product Classification
INGREDIENTS (11)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ETHIONAMIDEActive
Quantity: 250 mg in 1 1
Code: OAY8ORS3CQ
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT