Loxapine

Loxapine Capsules, USP

Approved

Approval ID

509bad3c-b563-4042-b270-d28bde19f224

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 28, 2020

Manufacturers

FDA

Lannett Company, Inc.

DUNS: 002277481

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Loxapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0527-1394

Application NumberANDA090695

Product Classification

Marketing Category

C73584

Generic Name

Loxapine

Product Specifications

Route of AdministrationORAL

Effective DateMay 28, 2020

FDA Product Classification

INGREDIENTS (18)

LOXAPINE SUCCINATEActive

Quantity: 5 mg in 1 1

Code: X59SG0MRYU

Classification: ACTIM

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLACRILIN POTASSIUMInactive

Code: 0BZ5A00FQU

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

D&C RED NO. 33Inactive

Code: 9DBA0SBB0L

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

Loxapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0527-1397

Application NumberANDA090695

Product Classification

Marketing Category

C73584

Generic Name

Loxapine

Product Specifications

Route of AdministrationORAL

Effective DateMay 28, 2020

FDA Product Classification

INGREDIENTS (17)

LOXAPINE SUCCINATEActive

Quantity: 50 mg in 1 1

Code: X59SG0MRYU

Classification: ACTIM

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLACRILIN POTASSIUMInactive

Code: 0BZ5A00FQU

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

Loxapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0527-1396

Application NumberANDA090695

Product Classification

Marketing Category

C73584

Generic Name

Loxapine

Product Specifications

Route of AdministrationORAL

Effective DateMay 28, 2020

FDA Product Classification

INGREDIENTS (23)

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

LOXAPINE SUCCINATEActive

Quantity: 25 mg in 1 1

Code: X59SG0MRYU

Classification: ACTIM

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLACRILIN POTASSIUMInactive

Code: 0BZ5A00FQU

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15

Classification: IACT

Loxapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0527-1395

Application NumberANDA090695

Product Classification

Marketing Category

C73584

Generic Name

Loxapine

Product Specifications

Route of AdministrationORAL

Effective DateMay 28, 2020

FDA Product Classification

INGREDIENTS (24)

LOXAPINE SUCCINATEActive

Quantity: 10 mg in 1 1

Code: X59SG0MRYU

Classification: ACTIM

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLACRILIN POTASSIUMInactive

Code: 0BZ5A00FQU

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

D&C RED NO. 33Inactive

Code: 9DBA0SBB0L

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

AI-Powered Research

Premium Access

Loxapine

Products 4

Loxapine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

Loxapine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Loxapine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (23)

Loxapine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (24)

MedPath

Product

Company

Legal