FDA.reportPublic FDA data

Lithium Carbonate

Product NDC
70518-1481
11-digit product format
705181481
Labeler code
70518
Product ID
70518-1481_4910b637-1083-f6b5-e063-6294a90adb25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA018558
Marketing category
NDA
Marketing start
2018-10-06
Substance
LITHIUM CARBONATE
Active strength
300 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LITHIUM CARBONATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2BMD2GNA4V
Rxcui197890

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-1481-02021-02-19C16284748780-1ba0f9c33-1479-a910-e053-dadaa90a0b85These 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 use LITHIUM CARBONATE tablets, for oral use LITHIUM CARBONATE capsules, for oral use Initial U.S. Approval: 1970
70518-1481-02021-01-29C16284748780-1ba0f9c33-1479-a910-e053-dadaa90a0b85These 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 use LITHIUM CARBONATE tablets, for oral use LITHIUM CARBONATE capsules, for oral use Initial U.S. Approval: 1970

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1481-0Lithium Carbonate30 in 1 BLISTER PACKTABLET309
70518-1481-1Lithium Carbonate30 in 1 BLISTER PACKTABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1481LITHIUM CARBONATE TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 2 package rows20250223_c84cce95-cfcb-4426-aac6-d2f48f946ada.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197890lithium carbonate 300 MG Oral TabletPSNc84cce95-cfcb-4426-aac6-d2f48f946ada9
197890lithium carbonate 300 MG Oral TabletSCDc84cce95-cfcb-4426-aac6-d2f48f946ada9
197890LiCO3 300 MG Oral TabletSYc84cce95-cfcb-4426-aac6-d2f48f946ada9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-1481-07051814810030 in 1 BLISTER PACKHistorical
70518-1481-17051814810130 TABLET in 1 BLISTER PACK (70518-1481-1) 30 tablet2023-06-08NoNoHistorical