FDA.reportPublic FDA data

Lithium Carbonate

Product NDC
68462-224
11-digit product format
684620224
Labeler code
68462
Product ID
68462-224_0072bf62-84d4-426b-aa03-bb7f8fef21c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA091616
Marketing category
ANDA
Marketing start
2011-02-14
Substance
LITHIUM CARBONATE
Active strength
450 mg/1
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lithium Carbonate
Brand name suffix
ER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LITHIUM CARBONATE450 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2BMD2GNA4V
Rxcui197892

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-224-01Lithium CarbonateER100 in 1 BOTTLETABLET10011
68462-224-10Lithium CarbonateER1000 in 1 BOTTLETABLET100011
68462-224-30Lithium CarbonateER30 in 1 BOTTLETABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-224-01EA - Each68462-224a3f831a6-684d-4c49-b95f-56171564d4c612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE ER (LITHIUM CARBONATE) TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE ER (LITHIUM CARBONATE) TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULITHIUM CARBONATE ER (LITHIUM CARBONATE) TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLITHIUM CARBONATE ER (LITHIUM CARBONATE) TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLITHIUM CARBONATE ER (LITHIUM CARBONATE) TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302LITHIUM CARBONATE ER (LITHIUM CARBONATE) TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LITHIUM CARBONATE ER (LITHIUM CARBONATE) TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQLITHIUM CARBONATE ER (LITHIUM CARBONATE) TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LITHIUM CARBONATE ER (LITHIUM CARBONATE) TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
TALCINACTIVE INGREDIENT7SEV7J4R1ULITHIUM CARBONATE ER (LITHIUM CARBONATE) TABLET [GLENMARK PHARMACEUTICALS INC., USA]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-224LITHIUM CARBONATE ER (LITHIUM CARBONATE) TABLET [GLENMARK PHARMACEUTICALS INC., USA]10Current NDC, Legacy NDC, 3 package rows20240105_525a9d9b-cbb1-4644-a28a-8bba96f09348.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197892lithium carbonate 450 MG Extended Release Oral TabletPSN525a9d9b-cbb1-4644-a28a-8bba96f0934811
197892lithium carbonate 450 MG Extended Release Oral TabletSCD525a9d9b-cbb1-4644-a28a-8bba96f0934811
197892LiCO3 450 MG Extended Release Oral TabletSY525a9d9b-cbb1-4644-a28a-8bba96f0934811
197892lithium carbonate 450 MG Extended Release Oral TabletPSNd8ddff4d-2b77-a8f2-e053-2a95a90a5fc03
197892lithium carbonate 450 MG Extended Release Oral TabletSCDd8ddff4d-2b77-a8f2-e053-2a95a90a5fc03
197892LiCO3 450 MG Extended Release Oral TabletSYd8ddff4d-2b77-a8f2-e053-2a95a90a5fc03
197892lithium carbonate 450 MG Extended Release Oral TabletPSN51b503f5-211f-a9cc-e063-6294a90a98951
197892lithium carbonate 450 MG Extended Release Oral TabletPSNbd4b07d3-ce42-440f-aec3-19f4d1c445a91
197892lithium carbonate 450 MG Extended Release Oral TabletSCD51b503f5-211f-a9cc-e063-6294a90a98951
197892lithium carbonate 450 MG Extended Release Oral TabletSCDbd4b07d3-ce42-440f-aec3-19f4d1c445a91
197892LiCO3 450 MG Extended Release Oral TabletSY51b503f5-211f-a9cc-e063-6294a90a98951
197892LiCO3 450 MG Extended Release Oral TabletSYbd4b07d3-ce42-440f-aec3-19f4d1c445a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-224-0168462022401100 TABLET in 1 BOTTLE (68462-224-01) 100 tablet2011-02-140000-00-00NoNoCurrent
68462-224-10684620224101000 TABLET in 1 BOTTLE (68462-224-10) 1000 tablet2011-02-140000-00-00NoNoCurrent
68462-224-306846202243030 TABLET in 1 BOTTLE (68462-224-30) 30 tablet2011-02-140000-00-00NoNoCurrent