Lithium Carbonate

Product NDC: 70518-4678
11-digit product format: 705184678
Labeler code: 70518
Product ID: 70518-4678_549da339-93ca-8503-e063-6294a90a1488
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium Carbonate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA076691
Marketing category: ANDA
Marketing start: 2026-06-19
Substance: LITHIUM CARBONATE
Active strength: 450 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
A076691-001	LITHIUM CARBONATE	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076691-001	AB

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	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076691-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076691-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076691-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076691-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076691-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076691-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076691-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076691-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076691-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076691-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076691-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076691-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076691-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076691-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076691-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076691-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076691-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076691-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076691-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076691-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076691-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076691-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076691-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076691-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076691-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076691-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076691-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076691-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076691-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076691-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076691-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076691-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076691-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076691-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076691-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076691-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076691-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076691-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076691-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076691-001	AB	1	`f41ea6bd6efb…`

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	450 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197892	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
aa900d48-a99f-4309-ba29-ecc894162750	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	REMEDYREPACK INC.	aa900d48-a99f-4309-ba29-ecc894162750	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076691 application number: ANDA076691 ndc (product): 70518-4678
Lithium Carbonate	LITHIUM CARBONATE	American Health Packaging	d276da3c-9952-4674-a54d-b1258df71b8a	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076691 application number: ANDA076691
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	edfceebd-a3e4-4905-bffe-cdc0b948dcd2	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076691 application number: ANDA076691
Lithium Carbonate	LITHIUM CARBONATE	Hikma Pharmaceuticals USA Inc.	a226a88d-eb57-4c96-afda-939801bca0a9	2023-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076691 application number: ANDA076691

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	Marketing start	Sample	Exclude flag	Status
70518-4678-0	70518467800	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4678-0)	2026-06-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lithium Carbonate Extended-Release Tablets USP, 450 mg	REMEDYREPACK INC.	2026-06-19	HUMAN PRESCRIPTION DRUG LABEL	1