Lithium Carbonate

Product NDC: 0054-0021
11-digit product format: 000540021
Labeler code: 0054
Product ID: 0054-0021_5e0351f3-360d-4044-a40a-a36f0008cf92
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium Carbonate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA076832
Marketing category: ANDA
Marketing start: 2004-10-28
Substance: LITHIUM CARBONATE
Active strength: 300 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
A076832-001	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2004-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076832-001	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	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076832-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-28	`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	A076832-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076832-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076832-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076832-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076832-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076832-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076832-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076832-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076832-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076832-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076832-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076832-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076832-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076832-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076832-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076832-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076832-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076832-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076832-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076832-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076832-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076832-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076832-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076832-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076832-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076832-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076832-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076832-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076832-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076832-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076832-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076832-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076832-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076832-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076832-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076832-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076832-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076832-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076832-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076832-001	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	300 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
197891	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
c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
8ce6e144-236f-b7be-f690-f06e0c8c6bd3	Product name	2	20170725
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
f09af6ee-c6dd-d0ce-77ad-93508bcdaced	Product name	4	20161205
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-0021-25	Lithium Carbonate	100 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	100		17
0054-0021-29	Lithium Carbonate	500 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	500		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0021-25	EA - Each	0054-0021	142ad14d-aff5-4e53-a777-4e9f134c65ab	1	2012-07-24
0054-0021-29	EA - Each	0054-0021	fe689341-41eb-4de2-8010-57bb8eda9c56	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LITHIUM CARBONATE	ACTIVE INGREDIENT	2BMD2GNA4V	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]	7
LITHIUM CATION	ACTIVE MOIETY	8H8Z5UER66	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]	7
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]	7
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]	7
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]	7
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ROXANE LABORATORIES, INC]	7
LITHIUM CARBONATE	ACTIVE INGREDIENT	2BMD2GNA4V	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
LITHIUM CATION	ACTIVE MOIETY	8H8Z5UER66	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
LITHIUM CARBONATE	ACTIVE INGREDIENT	2BMD2GNA4V	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
LITHIUM CARBONATE	ACTIVE INGREDIENT	2BMD2GNA4V	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
LITHIUM CATION	ACTIVE MOIETY	8H8Z5UER66	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
LITHIUM CATION	ACTIVE MOIETY	8H8Z5UER66	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
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
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	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
0054-0021	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [HIKMA PHARMACEUTICALS USA INC.]	17	Current NDC, Legacy NDC, 2 package rows	20230708_c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	453721b5-b1f5-4161-8e01-8b4803151dc5	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076832 application number: ANDA076832
Lithium Carbonate	LITHIUM CARBONATE	American Health Packaging	5ce5ebd2-f1b5-4c04-a7de-56a1b7eb8197	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076832 application number: ANDA076832
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	039f188c-413a-6e64-e063-6294a90a2972	2025-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076832 application number: ANDA076832
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	c2635909-7ab2-4c05-9a42-2819702dba63	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076832 application number: ANDA076832
Lithium Carbonate	LITHIUM CARBONATE	Hikma Pharmaceuticals USA Inc.	c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e	2023-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076832 application number: ANDA076832 ndc (product): 0054-0021

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
197891	lithium carbonate 300 MG Extended Release Oral Tablet	PSN	c2635909-7ab2-4c05-9a42-2819702dba63	24
197891	lithium carbonate 300 MG Extended Release Oral Tablet	SCD	c2635909-7ab2-4c05-9a42-2819702dba63	24
197891	LiCO3 300 MG Extended Release Oral Tablet	SY	c2635909-7ab2-4c05-9a42-2819702dba63	24
197891	lithium carbonate 300 MG Extended Release Oral Tablet	PSN	039f188c-413a-6e64-e063-6294a90a2972	21
197891	lithium carbonate 300 MG Extended Release Oral Tablet	SCD	039f188c-413a-6e64-e063-6294a90a2972	21
197891	LiCO3 300 MG Extended Release Oral Tablet	SY	039f188c-413a-6e64-e063-6294a90a2972	21
197891	lithium carbonate 300 MG Extended Release Oral Tablet	PSN	c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e	17
197891	lithium carbonate 300 MG Extended Release Oral Tablet	SCD	c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e	17
197891	LiCO3 300 MG Extended Release Oral Tablet	SY	c612b6c5-eeb9-4fdd-8c85-bb3d2147cd1e	17
197891	lithium carbonate 300 MG Extended Release Oral Tablet	PSN	5ce5ebd2-f1b5-4c04-a7de-56a1b7eb8197	9
197891	lithium carbonate 300 MG Extended Release Oral Tablet	SCD	5ce5ebd2-f1b5-4c04-a7de-56a1b7eb8197	9
197891	LiCO3 300 MG Extended Release Oral Tablet	SY	5ce5ebd2-f1b5-4c04-a7de-56a1b7eb8197	9
197891	lithium carbonate 300 MG Extended Release Oral Tablet	PSN	7f3aa4f5-908a-44e7-8113-b64f91dc86e7	4
197891	lithium carbonate 300 MG Extended Release Oral Tablet	SCD	7f3aa4f5-908a-44e7-8113-b64f91dc86e7	4
197891	LiCO3 300 MG Extended Release Oral Tablet	SY	7f3aa4f5-908a-44e7-8113-b64f91dc86e7	4
197891	lithium carbonate 300 MG Extended Release Oral Tablet	PSN	722ba14f-fd79-413e-bc1d-21fc10718e90	2
197891	lithium carbonate 300 MG Extended Release Oral Tablet	SCD	722ba14f-fd79-413e-bc1d-21fc10718e90	2
197891	LiCO3 300 MG Extended Release Oral Tablet	SY	722ba14f-fd79-413e-bc1d-21fc10718e90	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0021-25	00054002125	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0021-25)	2004-10-28	0000-00-00	No	No	Current
0054-0021-29	00054002129	500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0021-29)	2004-10-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lithium Carbonate Extended-release Tablets, USP 300 mg	REMEDYREPACK INC.	2026-06-19	HUMAN PRESCRIPTION DRUG LABEL	5
Lithium Carbonate Extended-release Tablets USP, 300 mg 8264001/1023F Rx only	American Health Packaging	2025-11-13	HUMAN PRESCRIPTION DRUG LABEL	9
Lithium Carbonate Extended-release Tablets, USP 300 mg	PD-Rx Pharmaceuticals, Inc.	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL	21
Lithium Carbonate Extended-release Tablets, USP 300 mg	PD-Rx Pharmaceuticals, Inc.	2025-01-20	HUMAN PRESCRIPTION DRUG LABEL	24
Lithium Carbonate Extended-release Tablets, USP 300 mg	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc. \| Livent USA Corp.	2023-07-28	HUMAN PRESCRIPTION DRUG LABEL	17
Lithium Carbonate Extended-release Tablets USP, 300 mg	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4
LITHIUM CARBONATE Extended Release Tablets USP, 300 mg	NCS HealthCare of KY, Inc dba Vangard Labs	2010-06-15	HUMAN PRESCRIPTION DRUG LABEL	6
LITHIUM CARBONATE Extended Release Tablets USP, 300 mg	Physicians Total Care, Inc.	2010-06-08	HUMAN PRESCRIPTION DRUG LABEL	2