Lithium Carbonate

Product NDC: 67046-1575
Requested package NDC: 67046-1575-3
11-digit product format: 670461575
Labeler code: 67046
Product ID: 67046-1575_3dfedfb7-e561-bc6d-e063-6294a90ac562
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium Carbonate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA091544
Marketing category: ANDA
Marketing start: 2025-09-04
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091544-001	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2010-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091544-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091544-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2010-12-27	`cb3db0bc1861…`

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	A091544-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091544-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091544-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091544-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091544-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091544-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091544-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091544-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091544-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091544-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091544-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091544-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091544-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091544-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091544-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091544-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091544-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091544-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091544-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091544-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091544-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091544-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091544-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091544-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091544-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091544-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091544-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091544-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091544-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091544-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091544-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091544-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091544-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091544-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091544-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091544-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091544-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091544-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091544-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091544-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lithium Carbonate
Listing expiration: 2026-12-31

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
3dfeeb11-a096-ae17-e063-6294a90a9aae	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	Strength	SPL version
67046-1575-3	Lithium Carbonate	30 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	30		1

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.	9cf3ceff-a237-44ea-b0dd-859e72c434d0	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091544 application number: ANDA091544
Lithium Carbonate	LITHIUM CARBONATE	Glenmark Pharmaceuticals Inc., USA	1b65d27e-5086-4a87-8387-c49f3d060978	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091544 application number: ANDA091544
Lithium Carbonate	LITHIUM CARBONATE	Coupler LLC	3dfeeb11-a096-ae17-e063-6294a90a9aae	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091544 application number: ANDA091544 ndc (package): 67046-1575-3 ndc (product): 67046-1575 ndc11 (package): 67046157503
Lithium Carbonate	LITHIUM CARBONATE	A-S Medication Solutions	3c996da2-c606-4043-9992-5bfb7f9b97a7	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091544 application number: ANDA091544

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	3dfeeb11-a096-ae17-e063-6294a90a9aae	1
197891	lithium carbonate 300 MG Extended Release Oral Tablet	SCD	3dfeeb11-a096-ae17-e063-6294a90a9aae	1
197891	LiCO3 300 MG Extended Release Oral Tablet	SY	3dfeeb11-a096-ae17-e063-6294a90a9aae	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67046-1575-3	67046157503	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (67046-1575-3)	2025-09-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lithium Carbonate Extended-Release Tablets Rx only	Coupler LLC	2025-09-04	HUMAN PRESCRIPTION DRUG LABEL	1