Lithium Carbonate

Product NDC
68084-640
11-digit product format
680840640
Labeler code
68084
Product ID
68084-640_437e7f3e-a3f5-cecd-e063-6294a90ac816
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA076832
Marketing category
ANDA
Marketing start
2014-10-13
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
Rxcui197891

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
68084-640-01Lithium Carbonate100 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE1009
68084-640-11Lithium Carbonate1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-640-01EA - Each68084-6405e758933-818d-4c72-a945-73912c4f8e2a12014-12-01
68084-640-11EA - Each68084-6407fdb6099-13cc-4ac3-9af6-4fdc4a40cb1e12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LLITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ELITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
SORBITOLINACTIVE INGREDIENT506T60A25RLITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
TRIACETININACTIVE INGREDIENTXHX3C3X673LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-640LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]8Current NDC, Legacy NDC, 2 package rows20240228_5ce5ebd2-f1b5-4c04-a7de-56a1b7eb8197.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197891lithium carbonate 300 MG Extended Release Oral TabletPSN5ce5ebd2-f1b5-4c04-a7de-56a1b7eb81979
197891lithium carbonate 300 MG Extended Release Oral TabletSCD5ce5ebd2-f1b5-4c04-a7de-56a1b7eb81979
197891LiCO3 300 MG Extended Release Oral TabletSY5ce5ebd2-f1b5-4c04-a7de-56a1b7eb81979

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-640-0168084064001100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-640-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-640-11) 100 blister pack2014-10-130000-00-00NoNoCurrent
68084-640-11680840640111 in 1 BLISTER PACKHistorical