Lithium Carbonate

Product NDC: 70518-3565
11-digit product format: 705183565
Labeler code: 70518
Product ID: 70518-3565_4f59ccaf-7413-bb25-e063-6394a90a64b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium Carbonate
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA079139
Marketing category: ANDA
Marketing start: 2022-10-31
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 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
A079139-001	LITHIUM CARBONATE	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03
A079139-002	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03
A079139-003	LITHIUM CARBONATE	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079139-001	AB
A079139-002	AB
A079139-003	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	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`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	A079139-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079139-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079139-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079139-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079139-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079139-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079139-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079139-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079139-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079139-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079139-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079139-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079139-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079139-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079139-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079139-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079139-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079139-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079139-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079139-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079139-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079139-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079139-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079139-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079139-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079139-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079139-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079139-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079139-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079139-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079139-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079139-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079139-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079139-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079139-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079139-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079139-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079139-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079139-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079139-001	AB	1	`8072bd15b7f6…`

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
57faf0b0-4380-4bbf-8de7-c3f9d74fc410	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
70518-3565-0	Lithium Carbonate	30 in 1 BLISTER PACK	CAPSULE	30	8
70518-3565-1	Lithium Carbonate	100 in 1 BOX	CAPSULE	100	8
70518-3565-2	Lithium Carbonate	1 in 1 POUCH	CAPSULE	1	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3565	LITHIUM CARBONATE CAPSULE [REMEDYREPACK INC.]	5	Current NDC, Legacy NDC, 3 package rows	20240327_57faf0b0-4380-4bbf-8de7-c3f9d74fc410.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	803eab29-0d0a-4df0-b504-bcd85ec01ead	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	1c320bff-b4d5-42f2-b2b5-238564fe9589	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139
Lithium Carbonate	LITHIUM CARBONATE	Bryant Ranch Prepack	1a62d5ae-a4a3-4b10-8281-feba134bbe3a	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139
Lithium Carbonate	LITHIUM CARBONATE	American Health Packaging	049902a9-3af1-4863-994e-15f36e7a9793	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139
Lithium Carbonate	LITHIUM CARBONATE	Coupler LLC	5102eb69-4872-53fb-e063-6394a90a8275	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	57faf0b0-4380-4bbf-8de7-c3f9d74fc410	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139 ndc (product): 70518-3565
Lithium Carbonate	LITHIUM CARBONATE	Glenmark Pharmaceuticals Inc., USA	63b3790f-a9b5-47f4-bae1-ddf8b43c13c1	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139
Lithium Carbonate	LITHIUM CARBONATE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	203386e3-718f-7c84-e063-6394a90aed34	2024-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139
Lithium Carbonate	LITHIUM CARBONATE	NCS HealthCare of KY, LLC dba Vangard Labs	204d94de-83e4-400e-bd6b-70b49813802c	2023-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139

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
311355	lithium carbonate 150 MG Oral Capsule	PSN	57faf0b0-4380-4bbf-8de7-c3f9d74fc410	8
311355	lithium carbonate 150 MG Oral Capsule	SCD	57faf0b0-4380-4bbf-8de7-c3f9d74fc410	8
311355	LiCO3 150 MG Oral Capsule	SY	57faf0b0-4380-4bbf-8de7-c3f9d74fc410	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3565-0	70518356500	30 CAPSULE in 1 BLISTER PACK (70518-3565-0)	30 capsule	2022-10-31	0000-00-00	No	No	Current
70518-3565-1	70518356501	100 POUCH in 1 BOX (70518-3565-1) / 1 CAPSULE in 1 POUCH (70518-3565-2)	100 pouch	2023-09-28		No	No	Current
70518-3565-2	70518356502	1 in 1 POUCH						Historical