Lithium Carbonate

Product NDC: 50090-3918
Requested package NDC: 50090-3918-0
11-digit product format: 500903918
Labeler code: 50090
Product ID: 50090-3918_6d9aae46-eba3-43cb-ad02-c33b765b37b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lithium carbonate
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA090702
Marketing category: ANDA
Marketing start: 2009-12-15
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: 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	50090-3918	50090-3918-0	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 · 15 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…`

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	Approval date
A090702-001	LITHIUM CARBONATE	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25
A090702-002	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25
A090702-003	LITHIUM CARBONATE	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090702-001	AB
A090702-002	AB
A090702-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090702-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-09-25	`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	A090702-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090702-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090702-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090702-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090702-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090702-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090702-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090702-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090702-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090702-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090702-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090702-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090702-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090702-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090702-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090702-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090702-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090702-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090702-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090702-001	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
50090-3918-0	2023-01-30	C162847	48780-1	f386c64a-3c86-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use LITHIUM CARBONATE CAPSULES safely and effectively. See full prescribing information for LITHIUM CARBONATE CAPSULES. 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
50090-3918-0	Lithium Carbonate	32 in 1 BOTTLE	CAPSULE	32		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3918	LITHIUM CARBONATE CAPSULE [A-S MEDICATION SOLUTIONS]	5	Legacy NDC, 1 package rows	20200122_d5593458-5965-48ad-9086-96f8651938dc.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	Coupler LLC	582697c1-063f-366f-e063-6294a90a8d1b	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702
lithium carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	01c4facd-ed79-4078-ba33-2044de372d0f	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702
lithium carbonate	LITHIUM CARBONATE	Bryant Ranch Prepack	bfececc8-b2ab-47d1-b126-1c6592bc9c26	2023-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702
lithium carbonate	LITHIUM CARBONATE	Camber Pharmaceuticals, Inc.	04518b80-7563-4544-bf05-04f286223faa	2022-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702
lithium carbonate	LITHIUM CARBONATE	Aphena Pharma Solutions - Tennessee, LLC	2b81eabc-5c5a-4b63-88d4-3f13b45a683e	2021-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702
Lithium Carbonate	LITHIUM CARBONATE	Proficient Rx LP	d3291474-8ef2-4cd8-aecc-2f550fd6a299	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090702 application number: ANDA090702

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
197889	lithium carbonate 300 MG Oral Capsule	PSN	d5593458-5965-48ad-9086-96f8651938dc	5
197889	lithium carbonate 300 MG Oral Capsule	SCD	d5593458-5965-48ad-9086-96f8651938dc	5
197889	LiCO3 300 MG Oral Capsule	SY	d5593458-5965-48ad-9086-96f8651938dc	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3918-0	50090391800	32 CAPSULE in 1 BOTTLE (50090-3918-0)	32 capsule	2018-12-06	0000-00-00	No	No	Current