Lithium Carbonate

Product NDC
58118-0545
Requested package NDC
58118-0545-8
11-digit product format
581180545
Labeler code
58118
Product ID
58118-0545_b02607c9-504d-b0d0-e053-2a95a90a7dc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
Clinical Solutions Wholesale
Application
ANDA090702
Marketing category
ANDA
Marketing start
2009-12-15
Marketing end
0000-00-00
Substance
LITHIUM CARBONATE
Active strength
300 mg/1
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage58118-054558118-0545-8DDiscontinued 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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A090702-001LITHIUM CARBONATELITHIUM CARBONATE150MGCAPSULE / ORALAB2009-09-25
A090702-002LITHIUM CARBONATELITHIUM CARBONATE300MGCAPSULE / ORALAB2009-09-25
A090702-003LITHIUM CARBONATELITHIUM CARBONATE600MGCAPSULE / ORALAB2009-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090702-001AB
A090702-002AB
A090702-003AB

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 UTC2026-02A090702-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090702-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090702-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090702-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090702-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090702-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090702-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090702-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090702-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090702-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090702-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090702-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090702-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090702-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090702-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090702-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090702-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090702-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090702-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090702-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090702-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090702-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090702-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090702-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090702-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090702-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090702-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090702-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A090702-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A090702-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090702-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090702-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090702-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090702-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-09-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090702-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-09-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090702-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090702-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-09-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090702-002LITHIUM CARBONATE300MGCAPSULE / ORALAB2009-09-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090702-003LITHIUM CARBONATE600MGCAPSULE / ORALAB2009-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090702-001LITHIUM CARBONATE150MGCAPSULE / ORALAB2009-09-258072bd15b7f6…

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 UTC2026-02A090702-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090702-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090702-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090702-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090702-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090702-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090702-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090702-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090702-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090702-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090702-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090702-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090702-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090702-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090702-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090702-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090702-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090702-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090702-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090702-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090702-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090702-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090702-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090702-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090702-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090702-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090702-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090702-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090702-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090702-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090702-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090702-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090702-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090702-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090702-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090702-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090702-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090702-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090702-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090702-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LITHIUM CARBONATEACTIVE INGREDIENT2BMD2GNA4VLITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]1
LITHIUM CATIONACTIVE MOIETY8H8Z5UER66LITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MLITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XLITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3LITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]1
GELATININACTIVE INGREDIENT2G86QN327LLITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302LITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]1
SHELLACINACTIVE INGREDIENT46N107B71OLITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0545LITHIUM CARBONATE CAPSULE [CLINICAL SOLUTIONS WHOLESALE]10Legacy NDC20200926_3ec62ecc-677d-4f61-88a3-1bd9d9108fd5.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
lithium carbonateLITHIUM CARBONATECoupler LLC582697c1-063f-366f-e063-6294a90a8d1b2026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090702
application number: ANDA090702
lithium carbonateLITHIUM CARBONATEREMEDYREPACK INC.01c4facd-ed79-4078-ba33-2044de372d0f2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090702
application number: ANDA090702
lithium carbonateLITHIUM CARBONATEBryant Ranch Prepackbfececc8-b2ab-47d1-b126-1c6592bc9c262023-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090702
application number: ANDA090702
lithium carbonateLITHIUM CARBONATECamber Pharmaceuticals, Inc.04518b80-7563-4544-bf05-04f286223faa2022-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090702
application number: ANDA090702
lithium carbonateLITHIUM CARBONATEAphena Pharma Solutions - Tennessee, LLC2b81eabc-5c5a-4b63-88d4-3f13b45a683e2021-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090702
application number: ANDA090702
Lithium CarbonateLITHIUM CARBONATEProficient Rx LPd3291474-8ef2-4cd8-aecc-2f550fd6a2992021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090702
application number: ANDA090702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58118-0545-85811805450830 CAPSULE in 1 BLISTER PACK (58118-0545-8) 30 capsule2009-12-150000-00-00NoNoCurrent