Lithium Carbonate

Product NDC: 51079-180
11-digit product format: 510790180
Labeler code: 51079
Product ID: 51079-180_d347e324-2fc2-8e90-e053-2995a90a1766
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lithium carbonate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Institutional Inc.
Application: ANDA202288
Marketing category: ANDA
Marketing start: 2012-08-10
Marketing end: 0000-00-00
Substance: LITHIUM CARBONATE
Active strength: 300 mg/1
Pharmacologic classes: Mood Stabilizer [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51079-180		D	Discontinued by firm		2026-09-14
excluded package	package	51079-180	51079-180-20	D	Discontinued by firm		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51079-180-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51079-180-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51079-180-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51079-180-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51079-180-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51079-180-20	`cdf11ea48f46…`	`ba0047e9e063…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202288-001	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL			2012-06-29

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 · 43 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
2026-09-14 22:38:34	2026-08	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2012-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2012-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2012-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2012-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2012-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202288-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-06-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202288-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202288-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202288-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202288-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202288-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202288-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202288-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202288-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202288-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202288-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202288-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202288-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202288-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202288-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202288-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202288-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202288-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202288-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202288-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202288-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202288-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202288-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202288-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202288-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202288-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202288-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202288-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202288-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202288-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202288-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202288-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202288-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202288-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202288-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202288-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202288-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202288-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51079-180-01	EA - Each	51079-180	15f8ff0b-7668-4dbc-98aa-a5ebe4626f63	1	2013-02-13
51079-180-20	EA - Each	51079-180	c8d16510-baff-4bc5-bd7c-78d0a6c00c40	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LITHIUM CARBONATE	ACTIVE INGREDIENT	2BMD2GNA4V	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
LITHIUM CATION	ACTIVE MOIETY	8H8Z5UER66	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	2

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	A-S Medication Solutions	baf59ee7-1c98-4f77-96c5-7b50b7acb8f4	2023-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202288 application number: ANDA202288

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2BMD2GNA4V	LITHIUM CARBONATE	554-13-2	LITHIUM CARBONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51079-180-20	51079018020	100 BLISTER PACK in 1 CARTON (51079-180-20) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (51079-180-01)	100 blister pack	2012-08-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lithium Carbonate - Mylan Institutional Inc.	Mylan Institutional Inc.	2024-07-31	HUMAN PRESCRIPTION DRUG LABEL	11