Lithium Carbonate

Product NDC: 68084-655
11-digit product format: 680840655
Labeler code: 68084
Product ID: 68084-655_437e7c62-fa63-3ec3-e063-6394a90a044d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium Carbonate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA076691
Marketing category: ANDA
Marketing start: 2014-01-03
Substance: LITHIUM CARBONATE
Active strength: 450 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
A076691-001	LITHIUM CARBONATE	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076691-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076691-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2004-01-05	`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	A076691-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076691-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076691-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076691-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076691-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076691-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076691-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076691-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076691-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076691-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076691-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076691-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076691-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076691-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076691-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076691-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076691-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076691-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076691-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076691-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076691-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076691-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076691-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076691-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076691-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076691-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076691-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076691-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076691-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076691-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076691-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076691-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076691-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076691-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076691-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076691-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076691-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076691-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076691-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076691-001	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	450 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
197892	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
d276da3c-9952-4674-a54d-b1258df71b8a	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
68084-655-01	Lithium Carbonate	100 in 1 BOX, UNIT-DOSE	TABLET, EXTENDED RELEASE	100		8
68084-655-11	Lithium Carbonate	1 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-655-01	EA - Each	68084-655	36833190-962b-4aeb-bda1-b41e76928cc0	1	2014-02-04
68084-655-11	EA - Each	68084-655	d93fd534-3360-4b49-9601-d75577a2eb43	1	2014-02-04

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
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	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
68084-655	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	7	Current NDC, Legacy NDC, 2 package rows	20240417_d276da3c-9952-4674-a54d-b1258df71b8a.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	aa900d48-a99f-4309-ba29-ecc894162750	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076691 application number: ANDA076691
Lithium Carbonate	LITHIUM CARBONATE	American Health Packaging	d276da3c-9952-4674-a54d-b1258df71b8a	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076691 application number: ANDA076691 ndc (product): 68084-655
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	edfceebd-a3e4-4905-bffe-cdc0b948dcd2	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076691 application number: ANDA076691
Lithium Carbonate	LITHIUM CARBONATE	Hikma Pharmaceuticals USA Inc.	a226a88d-eb57-4c96-afda-939801bca0a9	2023-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076691 application number: ANDA076691

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
197892	lithium carbonate 450 MG Extended Release Oral Tablet	PSN	d276da3c-9952-4674-a54d-b1258df71b8a	8
197892	lithium carbonate 450 MG Extended Release Oral Tablet	SCD	d276da3c-9952-4674-a54d-b1258df71b8a	8
197892	LiCO3 450 MG Extended Release Oral Tablet	SY	d276da3c-9952-4674-a54d-b1258df71b8a	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-655-01	68084065501	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-655-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-655-11)	100 blister pack	2014-01-03	0000-00-00	No	No	Current
68084-655-11	68084065511	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lithium Carbonate Extended-release Tablets, USP 450 mg Rx Only 8265501/1023F	American Health Packaging	2025-11-13	HUMAN PRESCRIPTION DRUG LABEL	8