Lithium Carbonate

Product NDC
70518-1481
11-digit product format
705181481
Labeler code
70518
Product ID
70518-1481_4910b637-1083-f6b5-e063-6294a90adb25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA018558
Marketing category
NDA
Marketing start
2018-10-06
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-148170518-1481-0DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
N018558-001LITHIUM CARBONATELITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018558-001AB

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 UTC2026-02N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-293f01610625f2…
2019-09-15 20:21 UTC2019-09N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018558-001LITHIUM CARBONATE300MGTABLET / ORALABRLD, RS1982-01-29cb3db0bc1861…

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 UTC2026-02N018558-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018558-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018558-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018558-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018558-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018558-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018558-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018558-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018558-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018558-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018558-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018558-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018558-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018558-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018558-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018558-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018558-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018558-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018558-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018558-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018558-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018558-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018558-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018558-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018558-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018558-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018558-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018558-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018558-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018558-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018558-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018558-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018558-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018558-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018558-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018558-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018558-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018558-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018558-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018558-001AB1cb3db0bc1861…

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 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
197890Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c84cce95-cfcb-4426-aac6-d2f48f946adaAvailable 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1481-0Lithium Carbonate30 in 1 BLISTER PACKTABLET309
70518-1481-1Lithium Carbonate30 in 1 BLISTER PACKTABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1481LITHIUM CARBONATE TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 2 package rows20250223_c84cce95-cfcb-4426-aac6-d2f48f946ada.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lithium CarbonateLITHIUM CARBONATEREMEDYREPACK INC.c84cce95-cfcb-4426-aac6-d2f48f946ada2026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018558
application number: NDA018558
ndc (product): 70518-1481
Lithium CarbonateLITHIUM CARBONATEPD-Rx Pharmaceuticals, Inc.d20ed2aa-aa56-4709-9e7a-9243c71465c92025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018558
application number: NDA018558
Lithium CarbonateLITHIUM CARBONATEHikma Pharmaceuticals USA Inc.7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e2022-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018558
application number: NDA018558

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197890lithium carbonate 300 MG Oral TabletPSNc84cce95-cfcb-4426-aac6-d2f48f946ada9
197890lithium carbonate 300 MG Oral TabletSCDc84cce95-cfcb-4426-aac6-d2f48f946ada9
197890LiCO3 300 MG Oral TabletSYc84cce95-cfcb-4426-aac6-d2f48f946ada9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-1481-07051814810030 in 1 BLISTER PACKHistorical
70518-1481-17051814810130 TABLET in 1 BLISTER PACK (70518-1481-1) 30 tablet2023-06-08NoNoCurrent