lithium carbonate

Product NDC
63629-1917
11-digit product format
636291917
Labeler code
63629
Product ID
63629-1917_6391a7eb-907d-418b-aa66-b39dc038f60e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lithium carbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090702
Marketing category
ANDA
Marketing start
2009-12-15
Substance
LITHIUM CARBONATE
Active strength
300 mg/1
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-1917DDiscontinued by firm2026-08-11
excluded packagepackage63629-191763629-1917-1DDiscontinued by firm2026-08-11

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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1917-1lithium carbonate1000 in 1 BOTTLECAPSULE1000103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1917-1EA - Each63629-191763a4cf82-0247-436f-9e54-79cf83f6491712021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1917LITHIUM CARBONATE (LITHIUM CARBONATE) CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20230127_cc6f07db-c9e6-4e2d-90f8-00868954594d.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197889lithium carbonate 300 MG Oral CapsulePSNcc6f07db-c9e6-4e2d-90f8-00868954594d103
197889lithium carbonate 300 MG Oral CapsuleSCDcc6f07db-c9e6-4e2d-90f8-00868954594d103
197889LiCO3 300 MG Oral CapsuleSYcc6f07db-c9e6-4e2d-90f8-00868954594d103
197889lithium carbonate 300 MG Oral CapsulePSN2b81eabc-5c5a-4b63-88d4-3f13b45a683e1
197889lithium carbonate 300 MG Oral CapsuleSCD2b81eabc-5c5a-4b63-88d4-3f13b45a683e1
197889LiCO3 300 MG Oral CapsuleSY2b81eabc-5c5a-4b63-88d4-3f13b45a683e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1917-1636291917011000 CAPSULE in 1 BOTTLE (63629-1917-1) 1000 capsule2009-12-150000-00-00NoNoCurrent