Lithium Carbonate

Product NDC: 70518-0608
11-digit product format: 705180608
Labeler code: 70518
Product ID: 70518-0608_55680448-d1a9-159e-e063-6294a90a5ae5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium Carbonate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA204779
Marketing category: ANDA
Marketing start: 2017-07-06
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-0608	70518-0608-1	D	Discontinued by firm		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A204779-001	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204779-001	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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204779-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-07-27	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A204779-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204779-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204779-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204779-001	AB	1	`a50c72e98297…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197891	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
611b0ea2-6378-4c8f-953d-87f6b35b0634	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3053bb1-353b-4a0b-bca5-28fe7228957c	Product name	2	20250124
8ce6e144-236f-b7be-f690-f06e0c8c6bd3	Product name	2	20170725
f09af6ee-c6dd-d0ce-77ad-93508bcdaced	Product name	4	20161205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-0608-0	Lithium Carbonate	30 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	30	15
70518-0608-1	Lithium Carbonate	100 in 1 BOX	TABLET, EXTENDED RELEASE	100	15
70518-0608-2	Lithium Carbonate	1 in 1 POUCH	TABLET, EXTENDED RELEASE	1	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-0608	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]	13	Current NDC, Legacy NDC, 3 package rows	20250429_611b0ea2-6378-4c8f-953d-87f6b35b0634.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	611b0ea2-6378-4c8f-953d-87f6b35b0634	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204779 application number: ANDA204779 ndc (product): 70518-0608
Lithium Carbonate	LITHIUM CARBONATE	Rising Pharma Holdings, Inc.	3418bdb6-12ac-4626-9de5-44987b73ae89	2025-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204779 application number: ANDA204779

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197891	lithium carbonate 300 MG Extended Release Oral Tablet	PSN	611b0ea2-6378-4c8f-953d-87f6b35b0634	15
197891	lithium carbonate 300 MG Extended Release Oral Tablet	SCD	611b0ea2-6378-4c8f-953d-87f6b35b0634	15
197891	LiCO3 300 MG Extended Release Oral Tablet	SY	611b0ea2-6378-4c8f-953d-87f6b35b0634	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0608-0	70518060800	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-0608-0)		2017-07-06	0000-00-00	No	No	Current
70518-0608-1	70518060801	100 POUCH in 1 BOX (70518-0608-1) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-0608-2)	100 pouch	2021-07-22	0000-00-00	No	No	Current
70518-0608-2	70518060802	1 in 1 POUCH						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lithium Carbonate Extended-Release Tablets USP 300 mg	REMEDYREPACK INC.	2026-06-29	HUMAN PRESCRIPTION DRUG LABEL	16