lithium carbonate

Product NDC
71335-0120
11-digit product format
713350120
Labeler code
71335
Product ID
71335-0120_8dcb81bf-5383-4227-8315-13469ad46a49
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

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…

Additional Listing Data#

Finished product
Yes
Brand name base
lithium carbonate
Listing expiration
2026-12-31

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
197889Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bfececc8-b2ab-47d1-b126-1c6592bc9c26Available 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
71335-0120-1lithium carbonate60 in 1 BOTTLECAPSULE606
71335-0120-2lithium carbonate100 in 1 BOTTLECAPSULE1006
71335-0120-3lithium carbonate30 in 1 BOTTLECAPSULE306
71335-0120-4lithium carbonate90 in 1 BOTTLECAPSULE906
71335-0120-5lithium carbonate120 in 1 BOTTLECAPSULE1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0120-1EA - Each71335-01206cc2fe5a-3791-4e8b-85f9-75f7c97306c712018-03-08
71335-0120-2EA - Each71335-0120e6aefc84-0f52-4705-8fb8-7d3ec26571a112018-03-08
71335-0120-3EA - Each71335-0120a576e120-0e2c-46ae-bd20-c1a4dd803efb12018-03-08
71335-0120-4EA - Each71335-01202e1154ab-c5eb-443d-8b0b-253e8335076d12018-03-08
71335-0120-5EA - Each71335-0120c503ba0e-8a2e-46bd-98f7-25692c52de0212018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0120LITHIUM CARBONATE (LITHIUM CARBONATE) CAPSULE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 5 package rows20230329_bfececc8-b2ab-47d1-b126-1c6592bc9c26.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
ndc (product): 71335-0120
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 CapsulePSNbfececc8-b2ab-47d1-b126-1c6592bc9c266
197889lithium carbonate 300 MG Oral CapsuleSCDbfececc8-b2ab-47d1-b126-1c6592bc9c266
197889LiCO3 300 MG Oral CapsuleSYbfececc8-b2ab-47d1-b126-1c6592bc9c266

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0120-17133501200160 CAPSULE in 1 BOTTLE (71335-0120-1) 60 capsule2021-12-160000-00-00NoNoCurrent
71335-0120-271335012002100 CAPSULE in 1 BOTTLE (71335-0120-2) 100 capsule2021-12-160000-00-00NoNoCurrent
71335-0120-37133501200330 CAPSULE in 1 BOTTLE (71335-0120-3) 30 capsule2021-12-160000-00-00NoNoCurrent
71335-0120-47133501200490 CAPSULE in 1 BOTTLE (71335-0120-4) 90 capsule2021-12-160000-00-00NoNoCurrent
71335-0120-571335012005120 CAPSULE in 1 BOTTLE (71335-0120-5) 120 capsule2021-12-160000-00-00NoNoCurrent