lithium carbonate

Product NDC: 71610-557
11-digit product format: 716100557
Labeler code: 71610
Product ID: 71610-557_b418ff9e-6e72-4171-915b-4c1ec67c13c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lithium carbonate
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA090702
Marketing category: ANDA
Marketing start: 2009-12-15
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 · 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 · 123 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090702-001	AB	1	`8072bd15b7f6…`

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
197889	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
2b81eabc-5c5a-4b63-88d4-3f13b45a683e	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
71610-557-70	lithium carbonate	120 in 1 BOTTLE	CAPSULE	120		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-557-70	EA - Each	71610-557	18efd077-d612-4cf4-9c33-e5f83447ef5d	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-557	LITHIUM CARBONATE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, Legacy NDC, 1 package rows	20210626_2b81eabc-5c5a-4b63-88d4-3f13b45a683e.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 · 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
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 ndc (product): 71610-557
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197889	lithium carbonate 300 MG Oral Capsule	PSN	2b81eabc-5c5a-4b63-88d4-3f13b45a683e	1
197889	lithium carbonate 300 MG Oral Capsule	SCD	2b81eabc-5c5a-4b63-88d4-3f13b45a683e	1
197889	LiCO3 300 MG Oral Capsule	SY	2b81eabc-5c5a-4b63-88d4-3f13b45a683e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-557-70	71610055770	120 CAPSULE in 1 BOTTLE (71610-557-70)	120 capsule	2021-05-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
lithium carbonate	Aphena Pharma Solutions - Tennessee, LLC	2021-06-24	HUMAN PRESCRIPTION DRUG LABEL	1