Trifluoperazine Hydrochloride
Approved
Approval ID
dc9f4282-1cd8-4f67-9dfc-ad627453256c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2013
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
trifluoperazine hydrochloride
PRODUCT DETAILS
NDC Product Code53808-0629
Application NumberANDA040209
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 30, 2013
Generic Nametrifluoperazine hydrochloride
INGREDIENTS (13)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TRIFLUOPERAZINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: 6P1Y2SNF5V
Classification: ACTIM
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
trifluoperazine hydrochloride
PRODUCT DETAILS
NDC Product Code53808-0819
Application NumberANDA040209
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 30, 2013
Generic Nametrifluoperazine hydrochloride
INGREDIENTS (16)
TRIFLUOPERAZINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 6P1Y2SNF5V
Classification: ACTIM
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT