Lithium Carbonate

Product NDC: 68084-640
Requested package NDC: 68084-640-01
11-digit product format: 680840640
Labeler code: 68084
Product ID: 68084-640_437e7f3e-a3f5-cecd-e063-6294a90ac816
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium Carbonate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA076832
Marketing category: ANDA
Marketing start: 2014-10-13
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
A076832-001	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2004-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076832-001	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	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`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	A076832-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076832-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076832-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076832-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076832-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076832-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076832-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076832-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076832-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076832-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076832-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076832-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076832-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076832-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076832-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076832-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076832-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076832-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076832-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076832-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076832-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076832-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076832-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076832-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076832-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076832-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076832-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076832-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076832-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076832-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076832-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076832-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076832-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076832-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076832-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076832-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076832-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076832-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076832-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076832-001	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
5ce5ebd2-f1b5-4c04-a7de-56a1b7eb8197	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
68084-640-01	Lithium Carbonate	100 in 1 BOX, UNIT-DOSE	TABLET, EXTENDED RELEASE	100		9
68084-640-11	Lithium Carbonate	1 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	1		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-640-01	EA - Each	68084-640	5e758933-818d-4c72-a945-73912c4f8e2a	1	2014-12-01
68084-640-11	EA - Each	68084-640	7fdb6099-13cc-4ac3-9af6-4fdc4a40cb1e	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LITHIUM CARBONATE	ACTIVE INGREDIENT	2BMD2GNA4V	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
LITHIUM CATION	ACTIVE MOIETY	8H8Z5UER66	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-640	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	8	Current NDC, Legacy NDC, 2 package rows	20240228_5ce5ebd2-f1b5-4c04-a7de-56a1b7eb8197.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	453721b5-b1f5-4161-8e01-8b4803151dc5	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076832 application number: ANDA076832
Lithium Carbonate	LITHIUM CARBONATE	American Health Packaging	5ce5ebd2-f1b5-4c04-a7de-56a1b7eb8197	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076832 application number: ANDA076832 ndc (package): 68084-640-01 ndc (product): 68084-640 ndc11 (package): 68084064001
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	039f188c-413a-6e64-e063-6294a90a2972	2025-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076832 application number: ANDA076832
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	c2635909-7ab2-4c05-9a42-2819702dba63	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076832 application number: ANDA076832
Lithium Carbonate	LITHIUM CARBONATE	Hikma Pharmaceuticals USA Inc.	c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e	2023-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076832 application number: ANDA076832

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	5ce5ebd2-f1b5-4c04-a7de-56a1b7eb8197	9
197891	lithium carbonate 300 MG Extended Release Oral Tablet	SCD	5ce5ebd2-f1b5-4c04-a7de-56a1b7eb8197	9
197891	LiCO3 300 MG Extended Release Oral Tablet	SY	5ce5ebd2-f1b5-4c04-a7de-56a1b7eb8197	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-640-01	68084064001	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-640-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-640-11)	100 blister pack	2014-10-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lithium Carbonate Extended-release Tablets USP, 300 mg 8264001/1023F Rx only	American Health Packaging	2025-11-13	HUMAN PRESCRIPTION DRUG LABEL	9