Lithium Carbonate

These highlights do not include all the information needed to use LITHIUM and LITHIUM CARBONATE safely and effectively. See full prescribing information for LITHIUM and LITHIUM CARBONATE.LITHIUM oral solution, for oral useLITHIUM CARBONATE tablets, for oral useLITHIUM CARBONATE capsules, for oral use Initial U.S. Approval: 1970

Approved

Approval ID

7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 22, 2022

Manufacturers

FDA

Hikma Pharmaceuticals USA Inc.

DUNS: 080189610

Products 9

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

Lithium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0054-8528

Application NumberNDA018558

Product Classification

Marketing Category

C73594

Generic Name

Lithium Carbonate

Product Specifications

Route of AdministrationORAL

Effective DateNovember 22, 2022

FDA Product Classification

INGREDIENTS (7)

LITHIUM CARBONATEActive

Quantity: 300 mg in 1 1

Code: 2BMD2GNA4V

Classification: ACTIB

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

CALCIUM STEARATEInactive

Code: 776XM7047L

Classification: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

Lithium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0054-3527

Application NumberNDA018421

Product Classification

Marketing Category

C73594

Generic Name

Lithium

Product Specifications

Route of AdministrationORAL

Effective DateNovember 22, 2022

FDA Product Classification

INGREDIENTS (7)

LITHIUM CITRATEActive

Quantity: 8 meq in 5 mL

Code: 5Z6E9K79YV

Classification: ACTIM

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

RASPBERRYInactive

Code: 4N14V5R27W

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

SORBITOLInactive

Code: 506T60A25R

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

Lithium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0054-2527

Application NumberNDA017812

Product Classification

Marketing Category

C73594

Generic Name

Lithium Carbonate

Product Specifications

Route of AdministrationORAL

Effective DateNovember 22, 2022

FDA Product Classification

INGREDIENTS (12)

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

LITHIUM CARBONATEActive

Quantity: 300 mg in 1 1

Code: 2BMD2GNA4V

Classification: ACTIB

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

Lithium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0054-2526

Application NumberNDA017812

Product Classification

Marketing Category

C73594

Generic Name

Lithium Carbonate

Product Specifications

Route of AdministrationORAL

Effective DateNovember 22, 2022

FDA Product Classification

INGREDIENTS (11)

LITHIUM CARBONATEActive

Quantity: 150 mg in 1 1

Code: 2BMD2GNA4V

Classification: ACTIB

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

Lithium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0054-8526

Application NumberNDA017812

Product Classification

Marketing Category

C73594

Generic Name

Lithium Carbonate

Product Specifications

Route of AdministrationORAL

Effective DateNovember 22, 2022

FDA Product Classification

INGREDIENTS (12)

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

LITHIUM CARBONATEActive

Quantity: 150 mg in 1 1

Code: 2BMD2GNA4V

Classification: ACTIB

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

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

SHELLACInactive

Code: 46N107B71O

Classification: IACT

Lithium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0054-4527

Application NumberNDA018558

Product Classification

Marketing Category

C73594

Generic Name

Lithium Carbonate

Product Specifications

Route of AdministrationORAL

Effective DateNovember 22, 2022

FDA Product Classification

INGREDIENTS (7)

CALCIUM STEARATEInactive

Code: 776XM7047L

Classification: IACT

POVIDONE K30Inactive

Code: U725QWY32X

Classification: IACT

LITHIUM CARBONATEActive

Quantity: 300 mg in 1 1

Code: 2BMD2GNA4V

Classification: ACTIB

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

Lithium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0054-8527

Application NumberNDA017812

Product Classification

Marketing Category

C73594

Generic Name

Lithium Carbonate

Product Specifications

Route of AdministrationORAL

Effective DateNovember 22, 2022

FDA Product Classification

INGREDIENTS (12)

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

LITHIUM CARBONATEActive

Quantity: 300 mg in 1 1

Code: 2BMD2GNA4V

Classification: ACTIB

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

Lithium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0054-2531

Application NumberNDA017812

Product Classification

Marketing Category

C73594

Generic Name

Lithium Carbonate

Product Specifications

Route of AdministrationORAL

Effective DateNovember 22, 2022

FDA Product Classification

INGREDIENTS (12)

LITHIUM CARBONATEActive

Quantity: 600 mg in 1 1

Code: 2BMD2GNA4V

Classification: ACTIB

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

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

Lithium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0054-8531

Application NumberNDA017812

Product Classification

Marketing Category

C73594

Generic Name

Lithium Carbonate

Product Specifications

Route of AdministrationORAL

Effective DateNovember 22, 2022

FDA Product Classification

INGREDIENTS (12)

LITHIUM CARBONATEActive

Quantity: 600 mg in 1 1

Code: 2BMD2GNA4V

Classification: ACTIB

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AI-Powered Research

Premium Access

Lithium Carbonate

Products 9

Lithium Carbonate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (7)

Lithium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (7)

Lithium Carbonate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

Lithium Carbonate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

Lithium Carbonate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

Lithium Carbonate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (7)

Lithium Carbonate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

Lithium Carbonate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

Lithium Carbonate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

MedPath

Product

Company

Legal