Levomilnacipran

These highlights do not include all the information needed to use LEVOMILNACIPRAN EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for LEVOMILNACIPRAN EXTENDED-RELEASE CAPSULES. LEVOMILNACIPRAN extended-release capsules, for oral use Initial U.S. Approval: 2009 (milnacipran)

Approved

Approval ID

bcbc5d92-e022-4a0d-ab4d-2b0d7aa68c58

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 16, 2023

Manufacturers

FDA

Amneal Pharmaceuticals LLC

DUNS: 123797875

Products 4

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

Levomilnacipran

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code65162-960

Application NumberANDA210790

Product Classification

Marketing Category

C73584

Generic Name

Levomilnacipran

Product Specifications

Route of AdministrationORAL

Effective DateDecember 13, 2023

FDA Product Classification

INGREDIENTS (19)

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

ETHYLCELLULOSE (20 MPA.S)Inactive

Code: BJG0S321QY

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

LEVOMILNACIPRAN HYDROCHLORIDEActive

Quantity: 40 mg in 1 1

Code: 371U2ZK31U

Classification: ACTIM

Levomilnacipran

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code65162-437

Application NumberANDA210790

Product Classification

Marketing Category

C73584

Generic Name

Levomilnacipran

Product Specifications

Route of AdministrationORAL

Effective DateDecember 13, 2023

FDA Product Classification

INGREDIENTS (19)

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

LEVOMILNACIPRAN HYDROCHLORIDEActive

Quantity: 80 mg in 1 1

Code: 371U2ZK31U

Classification: ACTIM

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ETHYLCELLULOSE (20 MPA.S)Inactive

Code: BJG0S321QY

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

Levomilnacipran

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code65162-411

Application NumberANDA210790

Product Classification

Marketing Category

C73584

Generic Name

Levomilnacipran

Product Specifications

Route of AdministrationORAL

Effective DateDecember 13, 2023

FDA Product Classification

INGREDIENTS (19)

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

ETHYLCELLULOSE (20 MPA.S)Inactive

Code: BJG0S321QY

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

LEVOMILNACIPRAN HYDROCHLORIDEActive

Quantity: 20 mg in 1 1

Code: 371U2ZK31U

Classification: ACTIM

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

Levomilnacipran

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code65162-455

Application NumberANDA210790

Product Classification

Marketing Category

C73584

Generic Name

Levomilnacipran

Product Specifications

Route of AdministrationORAL

Effective DateDecember 13, 2023

FDA Product Classification

INGREDIENTS (19)

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

ETHYLCELLULOSE (20 MPA.S)Inactive

Code: BJG0S321QY

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

LEVOMILNACIPRAN HYDROCHLORIDEActive

Quantity: 120 mg in 1 1

Code: 371U2ZK31U

Classification: ACTIM

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

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Levomilnacipran

Products 4

Levomilnacipran

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Levomilnacipran

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Levomilnacipran

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Levomilnacipran

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

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