Perphenazine
Perphenazine Tablets, USP Rx only
Approved
Approval ID
bb1a3d20-1f93-48a1-9e27-4712a8561757
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2017
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
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 Code0591-4103
Application NumberANDA207582
Product Classification
M
Marketing Category
C73584
G
Generic Name
Perphenazine
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2017
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PERPHENAZINEActive
Quantity: 8 mg in 1 1
Code: FTA7XXY4EZ
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Perphenazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-4101
Application NumberANDA207582
Product Classification
M
Marketing Category
C73584
G
Generic Name
Perphenazine
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2017
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PERPHENAZINEActive
Quantity: 2 mg in 1 1
Code: FTA7XXY4EZ
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Perphenazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-4102
Application NumberANDA207582
Product Classification
M
Marketing Category
C73584
G
Generic Name
Perphenazine
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2017
FDA Product Classification
INGREDIENTS (10)
PERPHENAZINEActive
Quantity: 4 mg in 1 1
Code: FTA7XXY4EZ
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Perphenazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-4104
Application NumberANDA207582
Product Classification
M
Marketing Category
C73584
G
Generic Name
Perphenazine
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2017
FDA Product Classification
INGREDIENTS (10)
PERPHENAZINEActive
Quantity: 16 mg in 1 1
Code: FTA7XXY4EZ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT