lithium carbonate

Product NDC: 67046-1690
11-digit product format: 670461690
Labeler code: 67046
Product ID: 67046-1690_5826968c-813f-f033-e063-6394a90aa252
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lithium carbonate
Dosage form: CAPSULE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA090702
Marketing category: ANDA
Marketing start: 2026-08-03
Substance: LITHIUM CARBONATE
Active strength: 150 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090702-001	LITHIUM CARBONATE	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25
A090702-002	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25
A090702-003	LITHIUM CARBONATE	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090702-001	AB
A090702-002	AB
A090702-003	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 4 · 129 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
2026-09-14 22:38:34	2026-08	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A090702-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090702-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090702-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090702-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090702-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090702-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090702-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090702-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090702-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090702-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090702-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090702-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090702-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090702-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090702-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-001	AB	1	`301d65b070ca…`

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	150 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
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
582697c1-063f-366f-e063-6294a90a8d1b	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
lithium carbonate	LITHIUM CARBONATE	Coupler LLC	582697c1-063f-366f-e063-6294a90a8d1b	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702 ndc (product): 67046-1690
lithium carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	01c4facd-ed79-4078-ba33-2044de372d0f	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702
lithium carbonate	LITHIUM CARBONATE	Bryant Ranch Prepack	bfececc8-b2ab-47d1-b126-1c6592bc9c26	2023-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702
lithium carbonate	LITHIUM CARBONATE	Camber Pharmaceuticals, Inc.	04518b80-7563-4544-bf05-04f286223faa	2022-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702
lithium carbonate	LITHIUM CARBONATE	Aphena Pharma Solutions - Tennessee, LLC	2b81eabc-5c5a-4b63-88d4-3f13b45a683e	2021-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702
Lithium Carbonate	LITHIUM CARBONATE	Proficient Rx LP	d3291474-8ef2-4cd8-aecc-2f550fd6a299	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702

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
67046-1690-3	67046169003	30 CAPSULE in 1 BLISTER PACK (67046-1690-3)	30 capsule	2026-08-03	No	No	Current