Lithium Carbonate

Product NDC: 0054-0886
11-digit product format: 000540886
Labeler code: 0054
Product ID: 0054-0886_e89451be-87c9-43df-b41f-b028e56e2c2f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium Carbonate
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: NDA018558
Marketing category: NDA
Marketing start: 2026-08-16
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018558-001	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET / ORAL		RLD, RS	1982-01-29

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL		RLD, RS	1982-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL		RLD, RS	1982-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018558-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018558-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018558-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018558-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018558-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018558-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018558-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018558-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018558-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018558-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018558-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018558-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018558-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018558-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018558-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018558-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018558-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018558-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018558-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018558-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018558-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018558-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018558-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018558-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018558-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018558-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018558-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018558-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018558-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018558-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018558-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018558-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018558-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018558-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018558-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018558-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018558-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018558-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018558-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018558-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Lithium Carbonate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LITHIUM CARBONATE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2BMD2GNA4V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197889	Internal RxNorm lookup
197890	Internal RxNorm lookup
197893	Internal RxNorm lookup
311355	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b839ff4b-f62d-41ab-a823-550a756d58ec	Available on FDA.report

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate	LITHIUM CARBONATE	Hikma Pharmaceuticals USA Inc.	b839ff4b-f62d-41ab-a823-550a756d58ec	2026-08-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018558 application number: NDA018558 ndc (product): 0054-0886
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	c84cce95-cfcb-4426-aac6-d2f48f946ada	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018558 application number: NDA018558
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	d20ed2aa-aa56-4709-9e7a-9243c71465c9	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018558 application number: NDA018558
Lithium Carbonate	LITHIUM CARBONATE	Hikma Pharmaceuticals USA Inc.	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	2022-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018558 application number: NDA018558

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2BMD2GNA4V	LITHIUM CARBONATE	554-13-2	LITHIUM CARBONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0054-0886-25	00054088625	100 TABLET in 1 BOTTLE (0054-0886-25)	100 tablet	2026-08-16	No	No	Current
0054-0886-31	00054088631	1000 TABLET in 1 BOTTLE (0054-0886-31)	1000 tablet	2026-08-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lithium Carbonate	Hikma Pharmaceuticals USA Inc. \| Hikma Pharmaceuticals LLC \| Livent USA Corp.	2026-08-16	HUMAN PRESCRIPTION DRUG LABEL	3