Lithium Carbonate

Product NDC
68462-224
11-digit product format
684620224
Labeler code
68462
Product ID
68462-224_0072bf62-84d4-426b-aa03-bb7f8fef21c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA091616
Marketing category
ANDA
Marketing start
2011-02-14
Substance
LITHIUM CARBONATE
Active strength
450 mg/1
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091616-001LITHIUM CARBONATELITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091616-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-143f01610625f2…
2019-09-15 20:21 UTC2019-09A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091616-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091616-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091616-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091616-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091616-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091616-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091616-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091616-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091616-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091616-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091616-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091616-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091616-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091616-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091616-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091616-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091616-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091616-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091616-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091616-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091616-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091616-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091616-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091616-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091616-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091616-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091616-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091616-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091616-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091616-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091616-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091616-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091616-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091616-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091616-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091616-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091616-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091616-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091616-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091616-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Lithium Carbonate
Brand name suffix
ER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LITHIUM CARBONATE450 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197892Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
525a9d9b-cbb1-4644-a28a-8bba96f09348Available on FDA.report

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
68462-224-01Lithium CarbonateER100 in 1 BOTTLETABLET10011
68462-224-10Lithium CarbonateER1000 in 1 BOTTLETABLET100011
68462-224-30Lithium CarbonateER30 in 1 BOTTLETABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-224-01EA - Each68462-224a3f831a6-684d-4c49-b95f-56171564d4c612012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-224LITHIUM CARBONATE ER (LITHIUM CARBONATE) TABLET [GLENMARK PHARMACEUTICALS INC., USA]10Current NDC, Legacy NDC, 3 package rows20240105_525a9d9b-cbb1-4644-a28a-8bba96f09348.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lithium Carbonate ERLITHIUM CARBONATECoupler LLC51b503f5-211f-a9cc-e063-6294a90a98952026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091616
application number: ANDA091616
Lithium Carbonate ERLITHIUM CARBONATEREMEDYREPACK INC.bd4b07d3-ce42-440f-aec3-19f4d1c445a92026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091616
application number: ANDA091616
Lithium Carbonate ERLITHIUM CARBONATEGlenmark Pharmaceuticals Inc., USA525a9d9b-cbb1-4644-a28a-8bba96f093482026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091616
application number: ANDA091616
ndc (product): 68462-224
Lithium Carbonate ERLITHIUM CARBONATEAvKAREd8ddff4d-2b77-a8f2-e053-2a95a90a5fc02026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091616
application number: ANDA091616

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197892lithium carbonate 450 MG Extended Release Oral TabletPSN525a9d9b-cbb1-4644-a28a-8bba96f0934811
197892lithium carbonate 450 MG Extended Release Oral TabletSCD525a9d9b-cbb1-4644-a28a-8bba96f0934811
197892LiCO3 450 MG Extended Release Oral TabletSY525a9d9b-cbb1-4644-a28a-8bba96f0934811
197892lithium carbonate 450 MG Extended Release Oral TabletPSNd8ddff4d-2b77-a8f2-e053-2a95a90a5fc03
197892lithium carbonate 450 MG Extended Release Oral TabletSCDd8ddff4d-2b77-a8f2-e053-2a95a90a5fc03
197892LiCO3 450 MG Extended Release Oral TabletSYd8ddff4d-2b77-a8f2-e053-2a95a90a5fc03
197892lithium carbonate 450 MG Extended Release Oral TabletPSN51b503f5-211f-a9cc-e063-6294a90a98951
197892lithium carbonate 450 MG Extended Release Oral TabletPSNbd4b07d3-ce42-440f-aec3-19f4d1c445a91
197892lithium carbonate 450 MG Extended Release Oral TabletSCD51b503f5-211f-a9cc-e063-6294a90a98951
197892lithium carbonate 450 MG Extended Release Oral TabletSCDbd4b07d3-ce42-440f-aec3-19f4d1c445a91
197892LiCO3 450 MG Extended Release Oral TabletSY51b503f5-211f-a9cc-e063-6294a90a98951
197892LiCO3 450 MG Extended Release Oral TabletSYbd4b07d3-ce42-440f-aec3-19f4d1c445a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-224-0168462022401100 TABLET in 1 BOTTLE (68462-224-01) 100 tablet2011-02-140000-00-00NoNoCurrent
68462-224-10684620224101000 TABLET in 1 BOTTLE (68462-224-10) 1000 tablet2011-02-140000-00-00NoNoCurrent
68462-224-306846202243030 TABLET in 1 BOTTLE (68462-224-30) 30 tablet2011-02-140000-00-00NoNoCurrent