Trezix
TREZIX™ Capsules
Approved
Approval ID
a519a201-bcfd-4029-9bdf-fc3e03f975ac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 3, 2021
Manufacturers
FDA
Wraser Llc
DUNS: 121828334
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
acetaminophen, caffeine, dihydrocodeine bitartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66992-840
Application NumberANDA204785
Product Classification
M
Marketing Category
C73584
G
Generic Name
acetaminophen, caffeine, dihydrocodeine bitartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2021
FDA Product Classification
INGREDIENTS (10)
ACETAMINOPHENActive
Quantity: 320.5 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CAFFEINEActive
Quantity: 30 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
DIHYDROCODEINE BITARTRATEActive
Quantity: 16 mg in 1 1
Code: 8LXS95BSA9
Classification: ACTIB