Lithium Carbonate

Product NDC: 42291-496
Requested package NDC: 42291-496-01
11-digit product format: 422910496
Labeler code: 42291
Product ID: 42291-496_485f83f8-8405-eae8-e063-6294a90a3c33
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium Carbonate
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA091616
Marketing category: ANDA
Marketing start: 2022-02-25
Substance: LITHIUM CARBONATE
Active strength: 450 mg/1
Pharmacologic classes: Mood Stabilizer [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A091616-001	LITHIUM CARBONATE	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091616-001	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	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091616-001	LITHIUM CARBONATE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-02-14	`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	A091616-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091616-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091616-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091616-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091616-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091616-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091616-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091616-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091616-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091616-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091616-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091616-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091616-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091616-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091616-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091616-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091616-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091616-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091616-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091616-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091616-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091616-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091616-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091616-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091616-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091616-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091616-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091616-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091616-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091616-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091616-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091616-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091616-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091616-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091616-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091616-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091616-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091616-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091616-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091616-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lithium Carbonate
Brand name suffix: ER
Listing expiration: 2027-12-31

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
d8ddff4d-2b77-a8f2-e053-2a95a90a5fc0	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
42291-496-01	Lithium CarbonateER	100 in 1 BOTTLE	TABLET	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-496-01	EA - Each	42291-496	17e62985-0fac-4e68-842f-a14f79079c1a	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-496	LITHIUM CARBONATE ER (LITHIUM CARBONATE) TABLET [AVKARE]	2	Current NDC, Legacy NDC, 1 package rows	20240110_d8ddff4d-2b77-a8f2-e053-2a95a90a5fc0.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 ER	LITHIUM CARBONATE	Coupler LLC	51b503f5-211f-a9cc-e063-6294a90a9895	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091616 application number: ANDA091616
Lithium Carbonate ER	LITHIUM CARBONATE	REMEDYREPACK INC.	bd4b07d3-ce42-440f-aec3-19f4d1c445a9	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091616 application number: ANDA091616
Lithium Carbonate ER	LITHIUM CARBONATE	Glenmark Pharmaceuticals Inc., USA	525a9d9b-cbb1-4644-a28a-8bba96f09348	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091616 application number: ANDA091616
Lithium Carbonate ER	LITHIUM CARBONATE	AvKARE	d8ddff4d-2b77-a8f2-e053-2a95a90a5fc0	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091616 application number: ANDA091616 ndc (package): 42291-496-01 ndc (product): 42291-496 ndc11 (package): 42291049601

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	d8ddff4d-2b77-a8f2-e053-2a95a90a5fc0	3
197892	lithium carbonate 450 MG Extended Release Oral Tablet	SCD	d8ddff4d-2b77-a8f2-e053-2a95a90a5fc0	3
197892	LiCO3 450 MG Extended Release Oral Tablet	SY	d8ddff4d-2b77-a8f2-e053-2a95a90a5fc0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-496-01	42291049601	100 TABLET in 1 BOTTLE (42291-496-01)	100 tablet	2022-02-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lithium Carbonate Extended-Release Tablets USP Rx Only	AvKARE	2026-01-14	HUMAN PRESCRIPTION DRUG LABEL	3