FDA.reportPublic FDA data

Lithium Carbonate

Product NDC
67046-397
11-digit product format
670460397
Labeler code
67046
Product ID
67046-397_a8f37e63-ec41-680b-e053-2a95a90a1f7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
NDA017812
Marketing category
NDA
Marketing start
1987-01-28
Marketing end
0000-00-00
Substance
LITHIUM CARBONATE
Active strength
150 mg/1
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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
67046-397-302022-01-28C16284748780-1d6a99b39-aaa9-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use LITHIUM and LITHIUM CARBONATE safely and effectively. See full prescribing information for LITHIUM and LITHIUM CARBONATE. LITHIUM oral solution, for oral use LITHIUM CARBONATE tablets, for oral use LITHIUM CARBONATE capsules, for oral use Initial U.S. Approval: 1970

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-397-30Lithium Carbonate30 in 1 BLISTER PACKCAPSULE, GELATIN COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-397LITHIUM CARBONATE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20200626_a8f37c66-0b88-4f7c-e053-2995a90a4dea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311355lithium carbonate 150 MG Oral CapsulePSNa8f37c66-0b88-4f7c-e053-2995a90a4dea1
311355lithium carbonate 150 MG Oral CapsuleSCDa8f37c66-0b88-4f7c-e053-2995a90a4dea1
311355LiCO3 150 MG Oral CapsuleSYa8f37c66-0b88-4f7c-e053-2995a90a4dea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-397-306704603973030 CAPSULE, GELATIN COATED in 1 BLISTER PACK (67046-397-30) 1987-01-280000-00-00NoNoCurrent