FDA.reportPublic FDA data

Lithium Carbonate

Product NDC
70518-0668
11-digit product format
705180668
Labeler code
70518
Product ID
70518-0668_47fab62b-30fd-0be2-e063-6294a90a1769
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA079139
Marketing category
ANDA
Marketing start
2017-08-10
Substance
LITHIUM CARBONATE
Active strength
300 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 CARBONATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2BMD2GNA4V
Rxcui197889

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0668-0Lithium Carbonate30 in 1 BLISTER PACKCAPSULE3015
70518-0668-1Lithium Carbonate30 in 1 BLISTER PACKCAPSULE3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0668LITHIUM CARBONATE CAPSULE [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 2 package rows20250429_1c320bff-b4d5-42f2-b2b5-238564fe9589.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197889lithium carbonate 300 MG Oral CapsulePSN1c320bff-b4d5-42f2-b2b5-238564fe958915
197889lithium carbonate 300 MG Oral CapsuleSCD1c320bff-b4d5-42f2-b2b5-238564fe958915
197889LiCO3 300 MG Oral CapsuleSY1c320bff-b4d5-42f2-b2b5-238564fe958915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0668-07051806680030 CAPSULE in 1 BLISTER PACK (70518-0668-0) 30 capsule2017-08-100000-00-00NoNoCurrent
70518-0668-17051806680130 CAPSULE in 1 BLISTER PACK (70518-0668-1) 30 capsule2023-12-19NoNoCurrent