Lithium Carbonate

Product NDC
68462-222
11-digit product format
684620222
Labeler code
68462
Product ID
68462-222_02893f26-d53b-43c9-81bf-100a9dce33a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA079139
Marketing category
ANDA
Marketing start
2009-02-03
Substance
LITHIUM CARBONATE
Active strength
600 mg/1
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079139-001LITHIUM CARBONATELITHIUM CARBONATE150MGCAPSULE / ORALAB2009-02-03
A079139-002LITHIUM CARBONATELITHIUM CARBONATE300MGCAPSULE / ORALAB2009-02-03
A079139-003LITHIUM CARBONATELITHIUM CARBONATE600MGCAPSULE / ORALAB2009-02-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A079139-001AB
A079139-002AB
A079139-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079139-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079139-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079139-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-02-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079139-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079139-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079139-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-02-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A079139-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079139-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079139-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-02-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079139-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079139-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079139-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-02-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079139-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079139-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079139-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-02-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079139-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079139-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079139-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-02-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079139-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079139-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079139-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-02-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079139-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-02-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079139-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-02-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079139-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-02-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079139-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-02-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079139-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-02-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079139-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-02-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079139-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-02-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A079139-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-02-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A079139-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-02-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079139-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-02-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079139-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-02-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079139-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-02-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079139-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-02-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079139-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-02-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079139-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-02-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079139-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-02-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079139-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-02-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079139-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-02-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079139-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-02-038072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A079139-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079139-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079139-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079139-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079139-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079139-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079139-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079139-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079139-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079139-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079139-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079139-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079139-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079139-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079139-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079139-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079139-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079139-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079139-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079139-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079139-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079139-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079139-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079139-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079139-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079139-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079139-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079139-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079139-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079139-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079139-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079139-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079139-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079139-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079139-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079139-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079139-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079139-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079139-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079139-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LITHIUM CARBONATE600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2BMD2GNA4VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197889Internal RxNorm lookup
197893Internal RxNorm lookup
311355Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
63b3790f-a9b5-47f4-bae1-ddf8b43c13c1Available on FDA.report

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
68462-222-01Lithium Carbonate100 in 1 BOTTLECAPSULE10013
68462-222-11Lithium Carbonate10 in 1 BLISTER PACKCAPSULE1013
68462-222-11Lithium Carbonate10 in 1 BOX, UNIT-DOSECAPSULE1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-222-01EA - Each68462-222aab0cd1f-b808-407d-aba8-ebd718e9578312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
GELATININACTIVE INGREDIENT2G86QN327LLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
SHELLACINACTIVE INGREDIENT46N107B71OLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
TALCINACTIVE INGREDIENT7SEV7J4R1ULITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-222LITHIUM CARBONATE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]12Current NDC, Legacy NDC, 3 package rows20231108_63b3790f-a9b5-47f4-bae1-ddf8b43c13c1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.803eab29-0d0a-4df0-b504-bcd85ec01ead2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079139
application number: ANDA079139
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.1c320bff-b4d5-42f2-b2b5-238564fe95892026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079139
application number: ANDA079139
Lithium CarbonateLITHIUM CARBONATEBryant Ranch Prepack1a62d5ae-a4a3-4b10-8281-feba134bbe3a2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079139
application number: ANDA079139
Lithium CarbonateLITHIUM CARBONATEAmerican Health Packaging049902a9-3af1-4863-994e-15f36e7a97932026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079139
application number: ANDA079139
Lithium CarbonateLITHIUM CARBONATECoupler LLC5102eb69-4872-53fb-e063-6394a90a82752026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079139
application number: ANDA079139
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.57faf0b0-4380-4bbf-8de7-c3f9d74fc4102026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079139
application number: ANDA079139
Lithium CarbonateLITHIUM CARBONATEGlenmark Pharmaceuticals Inc., USA63b3790f-a9b5-47f4-bae1-ddf8b43c13c12025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079139
application number: ANDA079139
ndc (product): 68462-222
Lithium CarbonateLITHIUM CARBONATEBoswell Pharmacy Services LLC d/b/a BPS Wholesale203386e3-718f-7c84-e063-6394a90aed342024-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079139
application number: ANDA079139
Lithium CarbonateLITHIUM CARBONATENCS HealthCare of KY, LLC dba Vangard Labs204d94de-83e4-400e-bd6b-70b49813802c2023-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079139
application number: ANDA079139

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311355lithium carbonate 150 MG Oral CapsulePSN63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
197889lithium carbonate 300 MG Oral CapsulePSN63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
197893lithium carbonate 600 MG Oral CapsulePSN63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
311355lithium carbonate 150 MG Oral CapsuleSCD63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
197889lithium carbonate 300 MG Oral CapsuleSCD63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
197893lithium carbonate 600 MG Oral CapsuleSCD63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
311355LiCO3 150 MG Oral CapsuleSY63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
197889LiCO3 300 MG Oral CapsuleSY63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
197893LiCO3 600 MG Oral CapsuleSY63b3790f-a9b5-47f4-bae1-ddf8b43c13c113
197893lithium carbonate 600 MG Oral CapsulePSN803eab29-0d0a-4df0-b504-bcd85ec01ead10
197893lithium carbonate 600 MG Oral CapsuleSCD803eab29-0d0a-4df0-b504-bcd85ec01ead10
197893LiCO3 600 MG Oral CapsuleSY803eab29-0d0a-4df0-b504-bcd85ec01ead10
197889lithium carbonate 300 MG Oral CapsulePSN049902a9-3af1-4863-994e-15f36e7a97932
197889lithium carbonate 300 MG Oral CapsuleSCD049902a9-3af1-4863-994e-15f36e7a97932
197889LiCO3 300 MG Oral CapsuleSY049902a9-3af1-4863-994e-15f36e7a97932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-222-0168462022201100 CAPSULE in 1 BOTTLE (68462-222-01) 100 capsule2009-02-030000-00-00NoNoCurrent
68462-222-116846202221110 BLISTER PACK in 1 BOX, UNIT-DOSE (68462-222-11) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2009-02-030000-00-00NoNoCurrent