FDA.reportPublic FDA data

Lithium Carbonate

Product NDC
68462-221
11-digit product format
684620221
Labeler code
68462
Product ID
68462-221_02893f26-d53b-43c9-81bf-100a9dce33a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA079139
Marketing category
ANDA
Marketing start
2009-02-03
Substance
LITHIUM CARBONATE
Active strength
300 mg/1
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lithium Carbonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LITHIUM CARBONATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2BMD2GNA4V
Rxcui197889, 197893, 311355

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-221-01Lithium Carbonate100 in 1 BOTTLECAPSULE10013
68462-221-10Lithium Carbonate1000 in 1 BOTTLECAPSULE100013
68462-221-11Lithium Carbonate10 in 1 CARTONCAPSULE1013
68462-221-11Lithium Carbonate10 in 1 BLISTER PACKCAPSULE1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-221-01EA - Each68462-221d3f02bfd-733f-423b-9a04-d6430b2d1b9112012-07-24
68462-221-10EA - Each68462-22133dcfe15-3d2d-4be8-881e-5541f843a7f512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
GELATININACTIVE INGREDIENT2G86QN327LLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
SHELLACINACTIVE INGREDIENT46N107B71OLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
TALCINACTIVE INGREDIENT7SEV7J4R1ULITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
GELATININACTIVE INGREDIENT2G86QN327LLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SHELLACINACTIVE INGREDIENT46N107B71OLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SHELLACINACTIVE INGREDIENT46N107B71OLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-221LITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]12Current NDC, Legacy NDC, 4 package rows20231108_63b3790f-a9b5-47f4-bae1-ddf8b43c13c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197889lithium carbonate 300 MG Oral CapsulePSN1c320bff-b4d5-42f2-b2b5-238564fe958915
197889lithium carbonate 300 MG Oral CapsuleSCD1c320bff-b4d5-42f2-b2b5-238564fe958915
197889LiCO3 300 MG Oral CapsuleSY1c320bff-b4d5-42f2-b2b5-238564fe958915
311355lithium carbonate 150 MG Oral CapsulePSN63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
197889lithium carbonate 300 MG Oral CapsulePSN63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
197893lithium carbonate 600 MG Oral CapsulePSN63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
311355lithium carbonate 150 MG Oral CapsuleSCD63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
197889lithium carbonate 300 MG Oral CapsuleSCD63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
197893lithium carbonate 600 MG Oral CapsuleSCD63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
311355LiCO3 150 MG Oral CapsuleSY63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
197889LiCO3 300 MG Oral CapsuleSY63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
197893LiCO3 600 MG Oral CapsuleSY63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
197889lithium carbonate 300 MG Oral CapsulePSN1a62d5ae-a4a3-4b10-8281-feba134bbe3a6
197889lithium carbonate 300 MG Oral CapsuleSCD1a62d5ae-a4a3-4b10-8281-feba134bbe3a6
197889LiCO3 300 MG Oral CapsuleSY1a62d5ae-a4a3-4b10-8281-feba134bbe3a6
197889lithium carbonate 300 MG Oral CapsulePSN7714d36e-1309-4fe2-9506-e7d0f5bce0302
197889lithium carbonate 300 MG Oral CapsulePSN049902a9-3af1-4863-994e-15f36e7a97932
197889lithium carbonate 300 MG Oral CapsuleSCD7714d36e-1309-4fe2-9506-e7d0f5bce0302
197889lithium carbonate 300 MG Oral CapsuleSCD049902a9-3af1-4863-994e-15f36e7a97932
197889LiCO3 300 MG Oral CapsuleSY7714d36e-1309-4fe2-9506-e7d0f5bce0302
197889LiCO3 300 MG Oral CapsuleSY049902a9-3af1-4863-994e-15f36e7a97932
197889lithium carbonate 300 MG Oral CapsulePSN266b92c5-867a-d024-e063-6394a90a38751
197889lithium carbonate 300 MG Oral CapsulePSN204d94de-83e4-400e-bd6b-70b49813802c1
197889lithium carbonate 300 MG Oral CapsulePSNe81a731d-433b-4709-b36b-d3463bcfe2e81
197889lithium carbonate 300 MG Oral CapsuleSCD266b92c5-867a-d024-e063-6394a90a38751
197889lithium carbonate 300 MG Oral CapsuleSCD204d94de-83e4-400e-bd6b-70b49813802c1
197889lithium carbonate 300 MG Oral CapsuleSCDe81a731d-433b-4709-b36b-d3463bcfe2e81
197889LiCO3 300 MG Oral CapsuleSY266b92c5-867a-d024-e063-6394a90a38751
197889LiCO3 300 MG Oral CapsuleSY204d94de-83e4-400e-bd6b-70b49813802c1
197889LiCO3 300 MG Oral CapsuleSYe81a731d-433b-4709-b36b-d3463bcfe2e81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-221-0168462022101100 CAPSULE in 1 BOTTLE (68462-221-01) 100 capsule2009-02-030000-00-00NoNoCurrent
68462-221-10684620221101000 CAPSULE in 1 BOTTLE (68462-221-10) 1000 capsule2009-02-030000-00-00NoNoCurrent
68462-221-116846202211110 BLISTER PACK in 1 CARTON (68462-221-11) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2009-02-030000-00-00NoNoCurrent