Lithium Carbonate

Product NDC
72789-174
11-digit product format
727890174
Labeler code
72789
Product ID
72789-174_2becc6b3-fa7f-6bdc-e063-6394a90a8098
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA018558
Marketing category
NDA
Marketing start
1982-01-29
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 42.

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 / ORALRLD, RS1982-01-29

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018558-001LITHIUM CARBONATE300MGTABLET / ORALRLD, RS1982-01-29caaa826d4ba7…
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…

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
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
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
d20ed2aa-aa56-4709-9e7a-9243c71465c9Available 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
72789-174-01Lithium Carbonate100 in 1 BOTTLE, PLASTICTABLET10026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-174-01EA - Each72789-1747fc6e081-f419-4b47-901c-5ba85caaf5fc12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-174LITHIUM CARBONATE TABLET [PD-RX PHARMACEUTICALS, INC.]26Current NDC, Legacy NDC, 1 package rows20250119_d20ed2aa-aa56-4709-9e7a-9243c71465c9.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
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
ndc (product): 72789-174
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 TabletPSNd20ed2aa-aa56-4709-9e7a-9243c71465c926
197890lithium carbonate 300 MG Oral TabletSCDd20ed2aa-aa56-4709-9e7a-9243c71465c926
197890LiCO3 300 MG Oral TabletSYd20ed2aa-aa56-4709-9e7a-9243c71465c926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-174-0172789017401100 TABLET in 1 BOTTLE, PLASTIC (72789-174-01) 100 tablet2021-03-090000-00-00NoNoCurrent