MedPath

PERPHENAZINE

Perphenazine Tablets, USP

Approved
Approval ID

96322bdc-2183-413b-b7d4-c7192ba7666c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 1, 2023

Manufacturers
FDA

Proficient Rx LP

DUNS: 079196022

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 Code71205-843
Application NumberANDA205056
Product Classification
M
Marketing Category
C73584
G
Generic Name
PERPHENAZINE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2023
FDA Product Classification

INGREDIENTS (11)

PERPHENAZINEActive
Quantity: 8 mg in 1 1
Code: FTA7XXY4EZ
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT

PERPHENAZINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71205-841
Application NumberANDA205056
Product Classification
M
Marketing Category
C73584
G
Generic Name
PERPHENAZINE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2023
FDA Product Classification

INGREDIENTS (11)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PERPHENAZINEActive
Quantity: 2 mg in 1 1
Code: FTA7XXY4EZ
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT

PERPHENAZINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71205-842
Application NumberANDA205056
Product Classification
M
Marketing Category
C73584
G
Generic Name
PERPHENAZINE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2023
FDA Product Classification

INGREDIENTS (11)

PERPHENAZINEActive
Quantity: 4 mg in 1 1
Code: FTA7XXY4EZ
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT

PERPHENAZINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71205-844
Application NumberANDA205056
Product Classification
M
Marketing Category
C73584
G
Generic Name
PERPHENAZINE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2023
FDA Product Classification

INGREDIENTS (11)

PERPHENAZINEActive
Quantity: 16 mg in 1 1
Code: FTA7XXY4EZ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

PERPHENAZINE - FDA Drug Approval Details