perphenazine
Perphenazine Tablets, USP Rx only
Approved
Approval ID
c209f1f6-f440-4366-8140-1d24cf0c2ce6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2023
Manufacturers
FDA
Zydus Pharmaceuticals (USA) Inc.
DUNS: 156861945
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
perphenazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-593
Application NumberANDA205232
Product Classification
M
Marketing Category
C73584
G
Generic Name
perphenazine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (9)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PERPHENAZINEActive
Quantity: 8 mg in 1 1
Code: FTA7XXY4EZ
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
perphenazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-592
Application NumberANDA205232
Product Classification
M
Marketing Category
C73584
G
Generic Name
perphenazine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (9)
PERPHENAZINEActive
Quantity: 4 mg in 1 1
Code: FTA7XXY4EZ
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
perphenazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-591
Application NumberANDA205232
Product Classification
M
Marketing Category
C73584
G
Generic Name
perphenazine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PERPHENAZINEActive
Quantity: 2 mg in 1 1
Code: FTA7XXY4EZ
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
perphenazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-594
Application NumberANDA205232
Product Classification
M
Marketing Category
C73584
G
Generic Name
perphenazine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PERPHENAZINEActive
Quantity: 16 mg in 1 1
Code: FTA7XXY4EZ
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT