Lithium Carbonate

Product NDC
0054-0020
11-digit product format
000540020
Labeler code
0054
Product ID
0054-0020_17dfc90a-8988-4e63-aaa0-9c88c4a7d1bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA076691
Marketing category
ANDA
Marketing start
2004-01-13
Substance
LITHIUM CARBONATE
Active strength
450 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076691-001LITHIUM CARBONATELITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076691-001AB

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 UTC2026-02A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-053f01610625f2…
2019-09-15 20:21 UTC2019-09A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076691-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALABRS2004-01-05cb3db0bc1861…

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 UTC2026-02A076691-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076691-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076691-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076691-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076691-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076691-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076691-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076691-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076691-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076691-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076691-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076691-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076691-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076691-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076691-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076691-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076691-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076691-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076691-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076691-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076691-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076691-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076691-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076691-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076691-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076691-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076691-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076691-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076691-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076691-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076691-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076691-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076691-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076691-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076691-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076691-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076691-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076691-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076691-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076691-001AB1cb3db0bc1861…

Additional Listing Data#

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

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
a226a88d-eb57-4c96-afda-939801bca0a9Available 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
0054-0020-25Lithium Carbonate100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0020-25EA - Each0054-0020f6a1ed46-2dff-4165-a8f8-d7bc3e7cc89112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]5
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]5
POVIDONEINACTIVE INGREDIENTFZ989GH94ELITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]5
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQLITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]5
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ELITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQLITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ELITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQLITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0020LITHIUM CARBONATE TABLET, EXTENDED RELEASE [HIKMA PHARMACEUTICALS USA INC.]15Current NDC, Legacy NDC, 1 package rows20230708_a226a88d-eb57-4c96-afda-939801bca0a9.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 CarbonateLITHIUM CARBONATEREMEDYREPACK INC.aa900d48-a99f-4309-ba29-ecc8941627502026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076691
application number: ANDA076691
Lithium CarbonateLITHIUM CARBONATEAmerican Health Packagingd276da3c-9952-4674-a54d-b1258df71b8a2025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076691
application number: ANDA076691
Lithium CarbonateLITHIUM CARBONATEPD-Rx Pharmaceuticals, Inc.edfceebd-a3e4-4905-bffe-cdc0b948dcd22025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076691
application number: ANDA076691
Lithium CarbonateLITHIUM CARBONATEHikma Pharmaceuticals USA Inc.a226a88d-eb57-4c96-afda-939801bca0a92023-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076691
application number: ANDA076691
ndc (product): 0054-0020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197892lithium carbonate 450 MG Extended Release Oral TabletPSNedfceebd-a3e4-4905-bffe-cdc0b948dcd223
197892lithium carbonate 450 MG Extended Release Oral TabletSCDedfceebd-a3e4-4905-bffe-cdc0b948dcd223
197892LiCO3 450 MG Extended Release Oral TabletSYedfceebd-a3e4-4905-bffe-cdc0b948dcd223
197892lithium carbonate 450 MG Extended Release Oral TabletPSNa226a88d-eb57-4c96-afda-939801bca0a915
197892lithium carbonate 450 MG Extended Release Oral TabletSCDa226a88d-eb57-4c96-afda-939801bca0a915
197892LiCO3 450 MG Extended Release Oral TabletSYa226a88d-eb57-4c96-afda-939801bca0a915
197892lithium carbonate 450 MG Extended Release Oral TabletPSNd276da3c-9952-4674-a54d-b1258df71b8a8
197892lithium carbonate 450 MG Extended Release Oral TabletSCDd276da3c-9952-4674-a54d-b1258df71b8a8
197892LiCO3 450 MG Extended Release Oral TabletSYd276da3c-9952-4674-a54d-b1258df71b8a8
197892lithium carbonate 450 MG Extended Release Oral TabletPSN9efc1d04-7aae-4ca9-9af6-ea6f3e095db24
197892lithium carbonate 450 MG Extended Release Oral TabletSCD9efc1d04-7aae-4ca9-9af6-ea6f3e095db24
197892LiCO3 450 MG Extended Release Oral TabletSY9efc1d04-7aae-4ca9-9af6-ea6f3e095db24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0054-0020-2500054002025100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0020-25) 2004-01-130000-00-00NoNoCurrent