Lithium Carbonate

Product NDC: 62756-430
11-digit product format: 627560430
Labeler code: 62756
Product ID: 62756-430_b0888aa2-be9d-4a45-81b2-a59493bc4892
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium Carbonate
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA091027
Marketing category: ANDA
Marketing start: 2010-07-08
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
A091027-001	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB		2010-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091027-001	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	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091027-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	2010-06-24	`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	A091027-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091027-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091027-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091027-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091027-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091027-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091027-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091027-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091027-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091027-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091027-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091027-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091027-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091027-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091027-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091027-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091027-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091027-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091027-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091027-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091027-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091027-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091027-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091027-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091027-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091027-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091027-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091027-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091027-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091027-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091027-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091027-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091027-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091027-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091027-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091027-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091027-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091027-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091027-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091027-001	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
197890	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
d3284649-ed4c-4096-987b-4ac16b8278f2	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
62756-430-08	Lithium Carbonate	100 in 1 BOTTLE	TABLET	100	9
62756-430-18	Lithium Carbonate	1000 in 1 BOTTLE	TABLET	1000	9
62756-430-83	Lithium Carbonate	30 in 1 BOTTLE	TABLET	30	9
62756-430-88	Lithium Carbonate	100 in 1 BOTTLE	TABLET	100	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62756-430-18	EA - Each	62756-430	aa548340-158d-4560-a0d3-82ae3a18c358	1	2012-07-24
62756-430-88	EA - Each	62756-430	c9f20959-c3d2-4131-a4d1-0d237430a599	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LITHIUM CARBONATE	ACTIVE INGREDIENT	2BMD2GNA4V	LITHIUM CARBONATE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
LITHIUM CATION	ACTIVE MOIETY	8H8Z5UER66	LITHIUM CARBONATE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	LITHIUM CARBONATE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LITHIUM CARBONATE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LITHIUM CARBONATE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LITHIUM CARBONATE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LITHIUM CARBONATE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LITHIUM CARBONATE TABLET [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-430	LITHIUM CARBONATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	9	Current NDC, Legacy NDC, 4 package rows	20231004_d3284649-ed4c-4096-987b-4ac16b8278f2.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate	LITHIUM CARBONATE	Sun Pharmaceutical Industries, Inc.	d3284649-ed4c-4096-987b-4ac16b8278f2	2023-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091027 application number: ANDA091027 ndc (product): 62756-430

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
197890	lithium carbonate 300 MG Oral Tablet	PSN	d3284649-ed4c-4096-987b-4ac16b8278f2	9
197890	lithium carbonate 300 MG Oral Tablet	SCD	d3284649-ed4c-4096-987b-4ac16b8278f2	9
197890	LiCO3 300 MG Oral Tablet	SY	d3284649-ed4c-4096-987b-4ac16b8278f2	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62756-430-08	62756043008	100 TABLET in 1 BOTTLE (62756-430-08)	100 tablet	2010-07-08	0000-00-00	No	No	Current
62756-430-18	62756043018	1000 TABLET in 1 BOTTLE (62756-430-18)	1000 tablet	2010-07-08	0000-00-00	No	No	Current
62756-430-83	62756043083	30 TABLET in 1 BOTTLE (62756-430-83)	30 tablet	2010-07-08	0000-00-00	No	No	Current
62756-430-88	62756043088	100 TABLET in 1 BOTTLE (62756-430-88)	100 tablet	2010-07-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lithium Carbonate	REMEDYREPACK INC.	2024-03-05	HUMAN PRESCRIPTION DRUG LABEL	7
Lithium Carbonate	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2023-10-02	Human Prescription Drug Label	9
Lithium Carbonate	REMEDYREPACK INC.	2021-01-15	HUMAN PRESCRIPTION DRUG LABEL	4