Lithium Carbonate

Product NDC
68462-223
11-digit product format
684620223
Labeler code
68462
Product ID
68462-223_851bb451-d546-4bc8-9c37-90b91c7ea5c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA091544
Marketing category
ANDA
Marketing start
2010-12-27
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
Rxcui197891

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-223-01Lithium Carbonate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-223-01EA - Each68462-223724ce5cf-f066-44f4-bc9c-5867851c49f912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LLITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
HYPROMELLOSE 2910 (15000 MPA.S)INACTIVE INGREDIENT288VBX44JCLITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
POVIDONE K30INACTIVE INGREDIENTU725QWY32XLITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
SORBITOLINACTIVE INGREDIENT506T60A25RLITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-223LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]12Current NDC, Legacy NDC, 1 package rows20240104_1b65d27e-5086-4a87-8387-c49f3d060978.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197891lithium carbonate 300 MG Extended Release Oral TabletPSN3c996da2-c606-4043-9992-5bfb7f9b97a716
197891lithium carbonate 300 MG Extended Release Oral TabletSCD3c996da2-c606-4043-9992-5bfb7f9b97a716
197891LiCO3 300 MG Extended Release Oral TabletSY3c996da2-c606-4043-9992-5bfb7f9b97a716
197891lithium carbonate 300 MG Extended Release Oral TabletPSN1b65d27e-5086-4a87-8387-c49f3d06097813
197891lithium carbonate 300 MG Extended Release Oral TabletSCD1b65d27e-5086-4a87-8387-c49f3d06097813
197891LiCO3 300 MG Extended Release Oral TabletSY1b65d27e-5086-4a87-8387-c49f3d06097813
197891lithium carbonate 300 MG Extended Release Oral TabletPSN9cf3ceff-a237-44ea-b0dd-859e72c434d04
197891lithium carbonate 300 MG Extended Release Oral TabletSCD9cf3ceff-a237-44ea-b0dd-859e72c434d04
197891LiCO3 300 MG Extended Release Oral TabletSY9cf3ceff-a237-44ea-b0dd-859e72c434d04
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 startMarketing endSampleExclude flagStatus
68462-223-0168462022301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-223-01) 2010-12-270000-00-00NoNoCurrent