FDA.reportPublic FDA data

Lithium Carbonate

Product NDC
0054-0020
11-digit product format
000540020
Labeler code
0054
Product ID
0054-0020_17dfc90a-8988-4e63-aaa0-9c88c4a7d1bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA076691
Marketing category
ANDA
Marketing start
2004-01-13
Substance
LITHIUM CARBONATE
Active strength
450 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 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
0054-0020-25Lithium Carbonate100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0020-25EA - Each0054-0020f6a1ed46-2dff-4165-a8f8-d7bc3e7cc89112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]5
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]5
POVIDONEINACTIVE INGREDIENTFZ989GH94ELITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]5
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQLITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]5
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ELITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQLITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ELITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQLITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0020LITHIUM CARBONATE TABLET, EXTENDED RELEASE [HIKMA PHARMACEUTICALS USA INC.]15Current NDC, Legacy NDC, 1 package rows20230708_a226a88d-eb57-4c96-afda-939801bca0a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197892lithium carbonate 450 MG Extended Release Oral TabletPSNedfceebd-a3e4-4905-bffe-cdc0b948dcd223
197892lithium carbonate 450 MG Extended Release Oral TabletSCDedfceebd-a3e4-4905-bffe-cdc0b948dcd223
197892LiCO3 450 MG Extended Release Oral TabletSYedfceebd-a3e4-4905-bffe-cdc0b948dcd223
197892lithium carbonate 450 MG Extended Release Oral TabletPSNa226a88d-eb57-4c96-afda-939801bca0a915
197892lithium carbonate 450 MG Extended Release Oral TabletSCDa226a88d-eb57-4c96-afda-939801bca0a915
197892LiCO3 450 MG Extended Release Oral TabletSYa226a88d-eb57-4c96-afda-939801bca0a915
197892lithium carbonate 450 MG Extended Release Oral TabletPSNd276da3c-9952-4674-a54d-b1258df71b8a8
197892lithium carbonate 450 MG Extended Release Oral TabletSCDd276da3c-9952-4674-a54d-b1258df71b8a8
197892LiCO3 450 MG Extended Release Oral TabletSYd276da3c-9952-4674-a54d-b1258df71b8a8
197892lithium carbonate 450 MG Extended Release Oral TabletPSN9efc1d04-7aae-4ca9-9af6-ea6f3e095db24
197892lithium carbonate 450 MG Extended Release Oral TabletSCD9efc1d04-7aae-4ca9-9af6-ea6f3e095db24
197892LiCO3 450 MG Extended Release Oral TabletSY9efc1d04-7aae-4ca9-9af6-ea6f3e095db24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0054-0020-2500054002025100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0020-25) 2004-01-130000-00-00NoNoCurrent