FDA.reportPublic FDA data

Lithium

Product NDC
0054-3527
11-digit product format
000543527
Labeler code
0054
Product ID
0054-3527_f6f46308-d9da-4d34-bd5b-31b948a552fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium
Dosage form
SOLUTION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA018421
Marketing category
NDA
Marketing start
1980-12-23
Marketing end
0000-00-00
Substance
LITHIUM CITRATE
Active strength
8 meq/5mL
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
0054-3527-63Lithium500 mL in 1 BOTTLESOLUTION50028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-3527-63ML - Milliliter0054-3527b59ac375-5b30-457e-add5-aaf821d6ef0e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
LITHIUM CITRATEACTIVE INGREDIENT5Z6E9K79YVLITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LLITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
GELATININACTIVE INGREDIENT2G86QN327LLITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQLITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
POVIDONE K30INACTIVE INGREDIENTU725QWY32XLITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
RASPBERRYINACTIVE INGREDIENT4N14V5R27WLITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
SHELLACINACTIVE INGREDIENT46N107B71OLITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
SORBITOLINACTIVE INGREDIENT506T60A25RLITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
TALCINACTIVE INGREDIENT7SEV7J4R1ULITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11
WATERINACTIVE INGREDIENT059QF0KO0RLITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-3527LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [HIKMA PHARMACEUTICALS USA INC.]28Legacy NDC, 1 package rows20231129_7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311355lithium carbonate 150 MG Oral CapsulePSN7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28
197889lithium carbonate 300 MG Oral CapsulePSN7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28
197890lithium carbonate 300 MG Oral TabletPSN7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28
197893lithium carbonate 600 MG Oral CapsulePSN7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28
756059lithium ion 8 MEQ in 5 mL Oral SolutionPSN7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28
311355lithium carbonate 150 MG Oral CapsuleSCD7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28
197889lithium carbonate 300 MG Oral CapsuleSCD7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28
197890lithium carbonate 300 MG Oral TabletSCD7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28
197893lithium carbonate 600 MG Oral CapsuleSCD7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28
756059lithium citrate 60 MG/ML Oral SolutionSCD7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28
311355LiCO3 150 MG Oral CapsuleSY7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28
197889LiCO3 300 MG Oral CapsuleSY7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28
197890LiCO3 300 MG Oral TabletSY7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28
197893LiCO3 600 MG Oral CapsuleSY7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28
756059lithium citrate eqv to lithium carbonate 300 MG per 5 ML (lithium ion 8 MEQ per 5 ML) Oral SyrupSY7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28
756059lithium ion 8 MEQ per 5 ML Oral SyrupSY7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-3527-6300054352763500 mL in 1 BOTTLE (0054-3527-63) 500 ml1980-12-230000-00-00NoNoCurrent