Lithium Carbonate

Product NDC
53808-0704
11-digit product format
538080704
Labeler code
53808
Product ID
53808-0704_ad095c76-cd86-41c4-b54a-6a1db4fa200c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA079139
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
LITHIUM CARBONATE
Active strength
300 mg/1
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0704-12019-10-21C16284748780-1956f9ecf-bd9f-621f-e053-dbdaa90a74adLithium Carbonate Capsules USP 150 mg, 300 mg and 600 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0704-1Lithium Carbonate30 in 1 BLISTER PACKCAPSULE302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
GELATININACTIVE INGREDIENT2G86QN327LLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SHELLACINACTIVE INGREDIENT46N107B71OLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0704LITHIUM CARBONATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20100324_7714d36e-1309-4fe2-9506-e7d0f5bce030.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197889lithium carbonate 300 MG Oral CapsulePSN7714d36e-1309-4fe2-9506-e7d0f5bce0302
197889lithium carbonate 300 MG Oral CapsuleSCD7714d36e-1309-4fe2-9506-e7d0f5bce0302
197889LiCO3 300 MG Oral CapsuleSY7714d36e-1309-4fe2-9506-e7d0f5bce0302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0704-15380807040130 in 1 BLISTER PACKHistorical