Lithium Carbonate

Manufacturing Establishments (2)

Livent USA Corp.

Labeler

Hikma Pharmaceuticals USA Inc.

DUNS Number

118134245

West-Ward Columbus Inc.

Labeler

Hikma Pharmaceuticals USA Inc.

DUNS Number

058839929

Products (9)

NDC Product Code

0054-8528

Application Number

NDA018558

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 22, 2022

Ingredients

Lithium carbonateActive

Code: 2BMD2GNA4VClass: ACTIBQuantity: 300 mg in 1 1

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

CALCIUM STEARATEInactive

Code: 776XM7047LClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

Lithium

NDC Product Code

0054-3527

Application Number

NDA018421

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 22, 2022

Ingredients

Lithium citrateActive

Code: 5Z6E9K79YVClass: ACTIMQuantity: 8 meq in 5 mL

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

RASPBERRYInactive

Code: 4N14V5R27WClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Lithium Carbonate

NDC Product Code

0054-2527

Application Number

NDA017812

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 22, 2022

Ingredients

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

Lithium carbonateActive

Code: 2BMD2GNA4VClass: ACTIBQuantity: 300 mg in 1 1

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Lithium Carbonate

NDC Product Code

0054-2526

Application Number

NDA017812

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 22, 2022

Ingredients

Lithium carbonateActive

Code: 2BMD2GNA4VClass: ACTIBQuantity: 150 mg in 1 1

TALCInactive

Code: 7SEV7J4R1UClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

Lithium Carbonate

NDC Product Code

0054-8526

Application Number

NDA017812

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 22, 2022

Ingredients

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

Lithium carbonateActive

Code: 2BMD2GNA4VClass: ACTIBQuantity: 150 mg in 1 1

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

Lithium Carbonate

NDC Product Code

0054-4527

Application Number

NDA018558

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 22, 2022

Ingredients

CALCIUM STEARATEInactive

Code: 776XM7047LClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

Lithium carbonateActive

Code: 2BMD2GNA4VClass: ACTIBQuantity: 300 mg in 1 1

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Lithium Carbonate

NDC Product Code

0054-8527

Application Number

NDA017812

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 22, 2022

Ingredients

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

Lithium carbonateActive

Code: 2BMD2GNA4VClass: ACTIBQuantity: 300 mg in 1 1

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Lithium Carbonate

NDC Product Code

0054-2531

Application Number

NDA017812

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 22, 2022

Ingredients

Lithium carbonateActive

Code: 2BMD2GNA4VClass: ACTIBQuantity: 600 mg in 1 1

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

Lithium Carbonate

NDC Product Code

0054-8531

Application Number

NDA017812

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 22, 2022

Ingredients

Lithium carbonateActive

Code: 2BMD2GNA4VClass: ACTIBQuantity: 600 mg in 1 1

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

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Lithium Carbonate

Manufacturing Establishments (2)

Products (9)

Lithium Carbonate

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Lithium Carbonate

Lithium Carbonate

Lithium Carbonate

Lithium Carbonate

Lithium Carbonate

Lithium Carbonate

Lithium Carbonate