Lithium Carbonate

Product NDC: 0054-2527
11-digit product format: 000542527
Labeler code: 0054
Product ID: 0054-2527_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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
0054-2527-25	Lithium Carbonate	100 in 1 BOTTLE	CAPSULE, GELATIN COATED	100		28
0054-2527-31	Lithium Carbonate	1000 in 1 BOTTLE	CAPSULE, GELATIN COATED	1000		28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-2527-25	EA - Each	0054-2527	a54ccb5b-997a-4a2a-b264-a27ef56a1885	1	2012-07-24
0054-2527-31	EA - Each	0054-2527	23fd566a-f548-4a57-afee-eac09d5c73b2	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 CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
LITHIUM CATION	ACTIVE MOIETY	8H8Z5UER66	LITHIUM CARBONATE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LITHIUM CARBONATE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LITHIUM CARBONATE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LITHIUM CARBONATE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LITHIUM CARBONATE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LITHIUM CARBONATE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LITHIUM CARBONATE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LITHIUM CARBONATE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LITHIUM CARBONATE CAPSULE, GELATIN COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	13
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 CAPSULE, GELATIN COATED [TYA PHARMACEUTICALS]	2
LITHIUM CARBONATE	ACTIVE INGREDIENT	2BMD2GNA4V	LITHIUM CARBONATE CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
LITHIUM CATION	ACTIVE MOIETY	8H8Z5UER66	LITHIUM CARBONATE CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
LITHIUM CATION	ACTIVE MOIETY	8H8Z5UER66	LITHIUM CARBONATE CAPSULE, GELATIN COATED [TYA PHARMACEUTICALS]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LITHIUM CARBONATE CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LITHIUM CARBONATE CAPSULE, GELATIN COATED [TYA PHARMACEUTICALS]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LITHIUM CARBONATE CAPSULE, GELATIN COATED [TYA PHARMACEUTICALS]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LITHIUM CARBONATE CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LITHIUM CARBONATE CAPSULE, GELATIN COATED [TYA PHARMACEUTICALS]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LITHIUM CARBONATE CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LITHIUM CARBONATE CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LITHIUM CARBONATE CAPSULE, GELATIN COATED [TYA PHARMACEUTICALS]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LITHIUM CARBONATE CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LITHIUM CARBONATE CAPSULE, GELATIN COATED [TYA PHARMACEUTICALS]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LITHIUM CARBONATE CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LITHIUM CARBONATE CAPSULE, GELATIN COATED [TYA PHARMACEUTICALS]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LITHIUM CARBONATE CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LITHIUM CARBONATE CAPSULE, GELATIN COATED [TYA PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LITHIUM CARBONATE CAPSULE, GELATIN COATED [TYA PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LITHIUM CARBONATE CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
LITHIUM CARBONATE	ACTIVE INGREDIENT	2BMD2GNA4V	LITHIUM CARBONATE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA]	1
LITHIUM CARBONATE	ACTIVE INGREDIENT	2BMD2GNA4V	LITHIUM CARBONATE CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
LITHIUM CATION	ACTIVE MOIETY	8H8Z5UER66	LITHIUM CARBONATE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA]	1
LITHIUM CATION	ACTIVE MOIETY	8H8Z5UER66	LITHIUM CARBONATE CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LITHIUM CARBONATE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LITHIUM CARBONATE CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LITHIUM CARBONATE CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LITHIUM CARBONATE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LITHIUM CARBONATE CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LITHIUM CARBONATE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LITHIUM CARBONATE CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LITHIUM CARBONATE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LITHIUM CARBONATE CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LITHIUM CARBONATE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LITHIUM CARBONATE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LITHIUM CARBONATE CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LITHIUM CARBONATE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LITHIUM CARBONATE CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LITHIUM CARBONATE CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LITHIUM CARBONATE CAPSULE, GELATIN COATED [CONTRACT PHARMACY SERVICES-PA]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-2527	LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	28	Current NDC, Legacy NDC, 2 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): 0054-2527

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	c4973d87-d014-42f4-ba13-ae628ca1a451	30
197889	lithium carbonate 300 MG Oral Capsule	SCD	c4973d87-d014-42f4-ba13-ae628ca1a451	30
197889	LiCO3 300 MG Oral Capsule	SY	c4973d87-d014-42f4-ba13-ae628ca1a451	30
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	3318680f-f60c-4c5e-844d-7c6b829ff179	2
197889	lithium carbonate 300 MG Oral Capsule	PSN	e2aa1b69-8f0a-4632-ba08-ca3d7e5e6de8	2
197889	lithium carbonate 300 MG Oral Capsule	SCD	e2aa1b69-8f0a-4632-ba08-ca3d7e5e6de8	2
197889	lithium carbonate 300 MG Oral Capsule	SCD	3318680f-f60c-4c5e-844d-7c6b829ff179	2
197889	LiCO3 300 MG Oral Capsule	SY	3318680f-f60c-4c5e-844d-7c6b829ff179	2
197889	LiCO3 300 MG Oral Capsule	SY	e2aa1b69-8f0a-4632-ba08-ca3d7e5e6de8	2
311355	lithium carbonate 150 MG Oral Capsule	PSN	d0e63bdb-f663-41f3-9bb2-f03f6c98a31a	1
197889	lithium carbonate 300 MG Oral Capsule	PSN	1bde6fe0-fc5a-4ad5-95a2-71d5ad7824c0	1
197889	lithium carbonate 300 MG Oral Capsule	PSN	d0e63bdb-f663-41f3-9bb2-f03f6c98a31a	1
311355	lithium carbonate 150 MG Oral Capsule	SCD	d0e63bdb-f663-41f3-9bb2-f03f6c98a31a	1
197889	lithium carbonate 300 MG Oral Capsule	SCD	d0e63bdb-f663-41f3-9bb2-f03f6c98a31a	1
197889	lithium carbonate 300 MG Oral Capsule	SCD	1bde6fe0-fc5a-4ad5-95a2-71d5ad7824c0	1
311355	LiCO3 150 MG Oral Capsule	SY	d0e63bdb-f663-41f3-9bb2-f03f6c98a31a	1
197889	LiCO3 300 MG Oral Capsule	SY	d0e63bdb-f663-41f3-9bb2-f03f6c98a31a	1
197889	LiCO3 300 MG Oral Capsule	SY	1bde6fe0-fc5a-4ad5-95a2-71d5ad7824c0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-2527-25	00054252725	100 CAPSULE, GELATIN COATED in 1 BOTTLE (0054-2527-25)	1980-11-26	0000-00-00	No	No	Current
0054-2527-31	00054252731	1000 CAPSULE, GELATIN COATED in 1 BOTTLE (0054-2527-31)	1980-11-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lithium Carbonate	PD-Rx Pharmaceuticals, Inc.	2025-10-08	HUMAN PRESCRIPTION DRUG LABEL	30
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	2022-10-28	HUMAN PRESCRIPTION DRUG LABEL	2
Lithium Carbonate	A-S Medication Solutions	2021-08-07	HUMAN PRESCRIPTION DRUG LABEL	14
LITHIUM CARBONATE Tablets USP, LITHIUM CARBONATE Capsules USP, LITHIUM Oral Solution USP	TYA Pharmaceuticals	2014-03-10	HUMAN PRESCRIPTION DRUG LABEL	2
LITHIUM CARBONATE Tablets USP LITHIUM CARBONATE Capsules USP LITHIUM Oral Solution USP	NCS HealthCare of KY, Inc dba Vangard Labs	2013-06-20	HUMAN PRESCRIPTION DRUG LABEL	13
LITHIUM CARBONATE Tablets USP, LITHIUM CARBONATE Capsules USP, LITHIUM Oral Solution USP	Aphena Pharma Solutions - Tennessee, Inc.	2012-07-18	HUMAN PRESCRIPTION DRUG LABEL	1
LITHIUM CARBONATE Tablets USP, LITHIUM CARBONATE Capsules USP, LITHIUM Oral Solution USP	Contract Pharmacy Services-PA	2010-04-07	HUMAN PRESCRIPTION DRUG LABEL	1
LITHIUM CARBONATE Tablets USP, LITHIUM CARBONATE Capsules USP, LITHIUM Oral Solution USP	State of Florida DOH Central Pharmacy	2010-03-08	HUMAN PRESCRIPTION DRUG LABEL	2