Fluphenazine Hydrochloride
Fluphenazine Hydrochloride Tablets, USP
Approved
Approval ID
7036f7c6-0792-400d-a1c7-54f21b2bd481
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2022
Manufacturers
FDA
Taro Pharmaceuticals U.S.A. Inc.
DUNS: 145186370
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 Code51672-4235
Application NumberANDA215674
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluphenazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2022
FDA Product Classification
INGREDIENTS (13)
Fluphenazine HydrochlorideActive
Quantity: 5 mg in 1 1
Code: ZOU145W1XL
Classification: ACTIB
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)Inactive
Code: 23ZQ42JZZH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
Fluphenazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4233
Application NumberANDA215674
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluphenazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2022
FDA Product Classification
INGREDIENTS (11)
Fluphenazine HydrochlorideActive
Quantity: 1 mg in 1 1
Code: ZOU145W1XL
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)Inactive
Code: 23ZQ42JZZH
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Fluphenazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4234
Application NumberANDA215674
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluphenazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2022
FDA Product Classification
INGREDIENTS (13)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)Inactive
Code: 23ZQ42JZZH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
D&C yellow no. 10 aluminum lakeInactive
Code: CQ3XH3DET6
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
Fluphenazine HydrochlorideActive
Quantity: 2.5 mg in 1 1
Code: ZOU145W1XL
Classification: ACTIB
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
Fluphenazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4236
Application NumberANDA215674
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluphenazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2022
FDA Product Classification
INGREDIENTS (13)
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
Fluphenazine HydrochlorideActive
Quantity: 10 mg in 1 1
Code: ZOU145W1XL
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)Inactive
Code: 23ZQ42JZZH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT