Lithium Carbonate

Product NDC: 0054-8527
11-digit product format: 000548527
Labeler code: 0054
Product ID: 0054-8527_a9e58e66-6569-4c3b-993f-b4236904296e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium Carbonate
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: NDA017812
Marketing category: NDA
Marketing start: 1980-11-26
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 · 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…`

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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197889	Internal RxNorm lookup
197890	Internal RxNorm lookup
197893	Internal RxNorm lookup
311355	Internal RxNorm lookup
756059	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
7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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
0054-8527-25	Lithium Carbonate	10 in 1 BLISTER PACK	CAPSULE, GELATIN COATED	10		28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-8527-25	EA - Each	0054-8527	8bd4f6a4-30a6-4fff-a004-f2f903318164	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 LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
LITHIUM CITRATE	ACTIVE INGREDIENT	5Z6E9K79YV	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
LITHIUM CATION	ACTIVE MOIETY	8H8Z5UER66	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
RASPBERRY	INACTIVE INGREDIENT	4N14V5R27W	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
WATER	INACTIVE INGREDIENT	059QF0KO0R	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC]	11
LITHIUM CARBONATE	ACTIVE INGREDIENT	2BMD2GNA4V	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
LITHIUM CATION	ACTIVE MOIETY	8H8Z5UER66	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
RASPBERRY	INACTIVE INGREDIENT	4N14V5R27W	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM (LITHIUM CARBONATE) SOLUTION [CARDINAL HEALTH]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-8527	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	28	Current NDC, Legacy NDC, 1 package rows	20231129_7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e.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 ndc (product): 0054-8527

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	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
197889	lithium carbonate 300 MG Oral Capsule	PSN	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
197890	lithium carbonate 300 MG Oral Tablet	PSN	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
197893	lithium carbonate 600 MG Oral Capsule	PSN	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
756059	lithium ion 8 MEQ in 5 mL Oral Solution	PSN	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
311355	lithium carbonate 150 MG Oral Capsule	SCD	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
197889	lithium carbonate 300 MG Oral Capsule	SCD	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
197890	lithium carbonate 300 MG Oral Tablet	SCD	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
197893	lithium carbonate 600 MG Oral Capsule	SCD	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
756059	lithium citrate 60 MG/ML Oral Solution	SCD	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
311355	LiCO3 150 MG Oral Capsule	SY	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
197889	LiCO3 300 MG Oral Capsule	SY	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
197890	LiCO3 300 MG Oral Tablet	SY	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
197893	LiCO3 600 MG Oral Capsule	SY	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
756059	lithium citrate eqv to lithium carbonate 300 MG per 5 ML (lithium ion 8 MEQ per 5 ML) Oral Syrup	SY	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
756059	lithium ion 8 MEQ per 5 ML Oral Syrup	SY	7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e	28
197889	lithium carbonate 300 MG Oral Capsule	PSN	0e6b0a2d-b79c-44d8-b785-5267df9e8f72	12
197889	lithium carbonate 300 MG Oral Capsule	SCD	0e6b0a2d-b79c-44d8-b785-5267df9e8f72	12
197889	LiCO3 300 MG Oral Capsule	SY	0e6b0a2d-b79c-44d8-b785-5267df9e8f72	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-8527-25	00054852725	10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (0054-8527-25)	1980-11-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lithium Carbonate	Cardinal Health 107, LLC	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	13
Lithium Carbonate	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc. \| Livent USA Corp.	2022-11-22	HUMAN PRESCRIPTION DRUG LABEL	28
Lithium Carbonate	A-S Medication Solutions	2021-08-07	HUMAN PRESCRIPTION DRUG LABEL	14