Lithium Carbonate

Product NDC
46708-148
11-digit product format
467080148
Labeler code
46708
Product ID
46708-148_fa1dd72f-c205-4377-881e-836882c4de47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA204445
Marketing category
ANDA
Marketing start
2017-02-21
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-148-08Lithium Carbonate80 in 1 CARTONTABLET, EXTENDED RELEASE805
46708-148-30Lithium Carbonate30 in 1 BOTTLETABLET, EXTENDED RELEASE305
46708-148-31Lithium Carbonate100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
46708-148-91Lithium Carbonate1000 in 1 BOTTLETABLET, EXTENDED RELEASE10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-148LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]5Current NDC, Legacy NDC, 4 package rows20230202_8e950a50-689d-4bf8-87ce-cffd43c6d5c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197891lithium carbonate 300 MG Extended Release Oral TabletPSN8e950a50-689d-4bf8-87ce-cffd43c6d5c25
197891lithium carbonate 300 MG Extended Release Oral TabletSCD8e950a50-689d-4bf8-87ce-cffd43c6d5c25
197891LiCO3 300 MG Extended Release Oral TabletSY8e950a50-689d-4bf8-87ce-cffd43c6d5c25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-148-084670801480880 TABLET, EXTENDED RELEASE in 1 CARTON (46708-148-08) 2017-02-210000-00-00NoNoCurrent
46708-148-304670801483030 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-148-30) 2017-02-210000-00-00NoNoCurrent
46708-148-3146708014831100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-148-31) 2017-02-210000-00-00NoNoCurrent
46708-148-91467080148911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-148-91) 2017-02-210000-00-00NoNoCurrent