Lithium Carbonate

Product NDC: 67046-397
Requested package NDC: 67046-397-30
11-digit product format: 670460397
Labeler code: 67046
Product ID: 67046-397_a8f37e63-ec41-680b-e053-2a95a90a1f7b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium Carbonate
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Contract Pharmacy Services-PA
Application: NDA017812
Marketing category: NDA
Marketing start: 1987-01-28
Marketing end: 0000-00-00
Substance: LITHIUM CARBONATE
Active strength: 150 mg/1
Pharmacologic classes: Mood Stabilizer [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67046-397	67046-397-30	I	Inactivated by FDA		2026-08-11

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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	RLD / RS	Approval date
N017812-001	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982
N017812-002	LITHIUM CARBONATE	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28
N017812-003	LITHIUM CARBONATE	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017812-001	AB
N017812-002	AB
N017812-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017812-002	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	RLD	1987-01-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017812-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	RLD, RS	1987-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017812-001	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`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	N017812-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017812-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017812-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017812-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017812-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017812-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017812-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017812-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017812-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017812-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017812-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017812-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017812-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017812-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017812-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017812-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017812-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017812-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017812-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017812-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017812-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017812-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017812-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017812-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017812-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017812-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017812-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017812-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017812-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017812-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017812-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017812-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017812-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017812-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017812-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017812-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017812-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017812-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017812-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017812-001	AB	1	`8072bd15b7f6…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67046-397-30	2022-01-28	C162847	48780-1	d6a99b39-aaa9-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use LITHIUM and LITHIUM CARBONATE safely and effectively. See full prescribing information for LITHIUM and LITHIUM CARBONATE. LITHIUM oral solution, for oral use LITHIUM CARBONATE tablets, for oral use LITHIUM CARBONATE capsules, for oral use Initial U.S. Approval: 1970

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67046-397-30	Lithium Carbonate	30 in 1 BLISTER PACK	CAPSULE, GELATIN COATED	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-397	LITHIUM CARBONATE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA]	1	Legacy NDC, 1 package rows	20200626_a8f37c66-0b88-4f7c-e053-2995a90a4dea.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	05312159-3d8a-45e0-99cb-b83a7b200cd3	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017812 application number: NDA017812
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	b074ca9f-66b2-4e83-b67d-cb317b46411b	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017812 application number: NDA017812
Lithium Carbonate	LITHIUM CARBONATE	Cardinal Health 107, LLC	0e6b0a2d-b79c-44d8-b785-5267df9e8f72	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017812 application number: NDA017812
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	16ebe1f9-501d-468b-a37d-f6a46f8f32d1	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017812 application number: NDA017812
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	c4973d87-d014-42f4-ba13-ae628ca1a451	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017812 application number: NDA017812
Lithium Carbonate	LITHIUM CARBONATE	Hikma Pharmaceuticals USA Inc.	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	2022-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017812 application number: NDA017812

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	a8f37c66-0b88-4f7c-e053-2995a90a4dea	1
311355	lithium carbonate 150 MG Oral Capsule	SCD	a8f37c66-0b88-4f7c-e053-2995a90a4dea	1
311355	LiCO3 150 MG Oral Capsule	SY	a8f37c66-0b88-4f7c-e053-2995a90a4dea	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67046-397-30	67046039730	30 CAPSULE, GELATIN COATED in 1 BLISTER PACK (67046-397-30)	1987-01-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lithium Carbonate	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2020-06-25	HUMAN PRESCRIPTION DRUG LABEL	1