Lithium Carbonate

Product NDC
67046-1575
11-digit product format
670461575
Labeler code
67046
Product ID
67046-1575_3dfedfb7-e561-bc6d-e063-6294a90ac562
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA091544
Marketing category
ANDA
Marketing start
2025-09-04
Substance
LITHIUM CARBONATE
Active strength
300 mg/1
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lithium Carbonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LITHIUM CARBONATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2BMD2GNA4V
Rxcui197891

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
67046-1575-3Lithium Carbonate30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197891lithium carbonate 300 MG Extended Release Oral TabletPSN3dfeeb11-a096-ae17-e063-6294a90a9aae1
197891lithium carbonate 300 MG Extended Release Oral TabletSCD3dfeeb11-a096-ae17-e063-6294a90a9aae1
197891LiCO3 300 MG Extended Release Oral TabletSY3dfeeb11-a096-ae17-e063-6294a90a9aae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1575-36704615750330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (67046-1575-3) 2025-09-04NoNoHistorical