Fluphenazine Hydrochloride
Fluphenazine Hydrochloride Tablets, USP Rx only
Approved
Approval ID
e73764e7-e666-4ad3-a029-04a528dc1c9e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 19, 2023
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluphenazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-689
Application NumberANDA218055
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluphenazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2023
FDA Product Classification
INGREDIENTS (9)
FLUPHENAZINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: ZOU145W1XL
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Fluphenazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-687
Application NumberANDA218055
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluphenazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2023
FDA Product Classification
INGREDIENTS (10)
FLUPHENAZINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: ZOU145W1XL
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Fluphenazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-686
Application NumberANDA218055
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluphenazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2023
FDA Product Classification
INGREDIENTS (9)
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FLUPHENAZINE HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: ZOU145W1XL
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Fluphenazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-688
Application NumberANDA218055
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluphenazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2023
FDA Product Classification
INGREDIENTS (11)
FLUPHENAZINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: ZOU145W1XL
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT