FDA.reportPublic FDA data

Lithium Carbonate

Product NDC
70518-2345
11-digit product format
705182345
Labeler code
70518
Product ID
70518-2345_4a03bc22-bc9a-028d-e063-6294a90a8e7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA017812
Marketing category
NDA
Marketing start
2019-10-04
Substance
LITHIUM CARBONATE
Active strength
600 mg/1
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lithium Carbonate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LITHIUM CARBONATE600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2BMD2GNA4V
Rxcui197893

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
70518-2345-0Lithium Carbonate100 in 1 BOXCAPSULE, GELATIN COATED10013
70518-2345-1Lithium Carbonate1 in 1 POUCHCAPSULE, GELATIN COATED113
70518-2345-2Lithium Carbonate30 in 1 BLISTER PACKCAPSULE, GELATIN COATED3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2345LITHIUM CARBONATE CAPSULE, GELATIN COATED [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 3 package rows20250312_b074ca9f-66b2-4e83-b67d-cb317b46411b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197893lithium carbonate 600 MG Oral CapsulePSNb074ca9f-66b2-4e83-b67d-cb317b46411b13
197893lithium carbonate 600 MG Oral CapsuleSCDb074ca9f-66b2-4e83-b67d-cb317b46411b13
197893LiCO3 600 MG Oral CapsuleSYb074ca9f-66b2-4e83-b67d-cb317b46411b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2345-070518234500100 POUCH in 1 BOX (70518-2345-0) > 1 CAPSULE, GELATIN COATED in 1 POUCH (70518-2345-1) 100 pouch2019-10-040000-00-00NoNoCurrent
70518-2345-1705182345011 in 1 POUCHHistorical
70518-2345-27051823450230 CAPSULE, GELATIN COATED in 1 BLISTER PACK (70518-2345-2) 2022-11-110000-00-00NoNoCurrent