FDA.reportPublic FDA data

Lithium Carbonate

Product NDC
70518-2312
11-digit product format
705182312
Labeler code
70518
Product ID
70518-2312_519114df-75c8-972d-e063-6394a90a0a70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA079139
Marketing category
ANDA
Marketing start
2019-09-13
Substance
LITHIUM CARBONATE
Active strength
600 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 CARBONATE600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2BMD2GNA4V
Rxcui197893

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
70518-2312-02023-03-09C16284748780-1f386c649-e89a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LITHIUM CARBONATE CAPSULES safely and effectively. See full prescribing information for LITHIUM CARBONATE CAPSULES. LITHIUM CARBONATE capsules, for oral use Initial U.S. Approval: 1970
70518-2312-02023-03-09C16284748780-1f386c649-e89a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LITHIUM CARBONATE CAPSULES safely and effectively. See full prescribing information for LITHIUM CARBONATE CAPSULES. LITHIUM CARBONATE capsules, for oral use Initial U.S. Approval: 1970
70518-2312-02023-01-30C16284748780-1f386c649-e89a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LITHIUM CARBONATE CAPSULES safely and effectively. See full prescribing information for LITHIUM CARBONATE CAPSULES. LITHIUM CARBONATE capsules, for oral use Initial U.S. Approval: 1970
70518-2312-02023-01-30C16284748780-1f386c649-e89a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LITHIUM CARBONATE CAPSULES safely and effectively. See full prescribing information for LITHIUM CARBONATE CAPSULES. LITHIUM CARBONATE capsules, for oral use Initial U.S. Approval: 1970

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2312-0Lithium Carbonate100 in 1 BOXCAPSULE10010
70518-2312-1Lithium Carbonate1 in 1 POUCHCAPSULE110
70518-2312-2Lithium Carbonate70 in 1 BOX, UNIT-DOSECAPSULE7010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2312LITHIUM CARBONATE CAPSULE [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 3 package rows20250311_803eab29-0d0a-4df0-b504-bcd85ec01ead.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197893lithium carbonate 600 MG Oral CapsulePSN803eab29-0d0a-4df0-b504-bcd85ec01ead10
197893lithium carbonate 600 MG Oral CapsuleSCD803eab29-0d0a-4df0-b504-bcd85ec01ead10
197893LiCO3 600 MG Oral CapsuleSY803eab29-0d0a-4df0-b504-bcd85ec01ead10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2312-070518231200100 POUCH in 1 BOX (70518-2312-0) / 1 CAPSULE in 1 POUCH (70518-2312-1) 100 pouch2019-09-130000-00-00NoNoCurrent
70518-2312-1705182312011 in 1 POUCHHistorical
70518-2312-27051823120270 POUCH in 1 BOX, UNIT-DOSE (70518-2312-2) / 1 CAPSULE in 1 POUCH (70518-2312-1) 70 pouch2026-05-11NoNoCurrent