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Perphenazine

Perphenazine Tablets, USP

Approved
Approval ID

0dc77ea9-32ee-4b6d-b69d-8c712bcf5fe4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 20, 2022

Manufacturers
FDA

Major Pharmaceuticals

DUNS: 191427277

Products 3

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 Code0904-6601
Application NumberANDA040226
Product Classification
M
Marketing Category
C73584
G
Generic Name
perphenazine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2018
FDA Product Classification

INGREDIENTS (11)

PERPHENAZINEActive
Quantity: 8 mg in 1 1
Code: FTA7XXY4EZ
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT

perphenazine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0904-6600
Application NumberANDA040226
Product Classification
M
Marketing Category
C73584
G
Generic Name
perphenazine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2018
FDA Product Classification

INGREDIENTS (11)

PERPHENAZINEActive
Quantity: 4 mg in 1 1
Code: FTA7XXY4EZ
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT

perphenazine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0904-6599
Application NumberANDA040226
Product Classification
M
Marketing Category
C73584
G
Generic Name
perphenazine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2018
FDA Product Classification

INGREDIENTS (11)

PERPHENAZINEActive
Quantity: 2 mg in 1 1
Code: FTA7XXY4EZ
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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Perphenazine - FDA Drug Approval Details