FDA.reportPublic FDA data

Lithium Carbonate

Product NDC
0054-0021
11-digit product format
000540021
Labeler code
0054
Product ID
0054-0021_5e0351f3-360d-4044-a40a-a36f0008cf92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA076832
Marketing category
ANDA
Marketing start
2004-10-28
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0021-25Lithium Carbonate100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE10017
0054-0021-29Lithium Carbonate500 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0021-25EA - Each0054-0021142ad14d-aff5-4e53-a777-4e9f134c65ab12012-07-24
0054-0021-29EA - Each0054-0021fe689341-41eb-4de2-8010-57bb8eda9c5612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]7
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]7
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LLITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]7
POVIDONEINACTIVE INGREDIENTFZ989GH94ELITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]7
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]7
SORBITOLINACTIVE INGREDIENT506T60A25RLITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]7
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LLITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LLITHIUM CARBONATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ELITHIUM CARBONATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ELITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLITHIUM CARBONATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLITHIUM CARBONATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RLITHIUM CARBONATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RLITHIUM 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
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
0054-0021LITHIUM CARBONATE TABLET, EXTENDED RELEASE [HIKMA PHARMACEUTICALS USA INC.]17Current NDC, Legacy NDC, 2 package rows20230708_c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197891lithium carbonate 300 MG Extended Release Oral TabletPSNc2635909-7ab2-4c05-9a42-2819702dba6324
197891lithium carbonate 300 MG Extended Release Oral TabletSCDc2635909-7ab2-4c05-9a42-2819702dba6324
197891LiCO3 300 MG Extended Release Oral TabletSYc2635909-7ab2-4c05-9a42-2819702dba6324
197891lithium carbonate 300 MG Extended Release Oral TabletPSN039f188c-413a-6e64-e063-6294a90a297221
197891lithium carbonate 300 MG Extended Release Oral TabletSCD039f188c-413a-6e64-e063-6294a90a297221
197891LiCO3 300 MG Extended Release Oral TabletSY039f188c-413a-6e64-e063-6294a90a297221
197891lithium carbonate 300 MG Extended Release Oral TabletPSNc612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e17
197891lithium carbonate 300 MG Extended Release Oral TabletSCDc612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e17
197891LiCO3 300 MG Extended Release Oral TabletSYc612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e17
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
197891lithium carbonate 300 MG Extended Release Oral TabletPSN7f3aa4f5-908a-44e7-8113-b64f91dc86e74
197891lithium carbonate 300 MG Extended Release Oral TabletSCD7f3aa4f5-908a-44e7-8113-b64f91dc86e74
197891LiCO3 300 MG Extended Release Oral TabletSY7f3aa4f5-908a-44e7-8113-b64f91dc86e74
197891lithium carbonate 300 MG Extended Release Oral TabletPSN722ba14f-fd79-413e-bc1d-21fc10718e902
197891lithium carbonate 300 MG Extended Release Oral TabletSCD722ba14f-fd79-413e-bc1d-21fc10718e902
197891LiCO3 300 MG Extended Release Oral TabletSY722ba14f-fd79-413e-bc1d-21fc10718e902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0054-0021-2500054002125100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0021-25) 2004-10-280000-00-00NoNoCurrent
0054-0021-2900054002129500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0021-29) 2004-10-280000-00-00NoNoCurrent