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

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 Identifiers#

Field, Values table
Field	Values
Unii	2BMD2GNA4V
Rxcui	197889, 197890, 197893, 311355, 756059

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 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 [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
LITHIUM CARBONATE	ACTIVE INGREDIENT	2BMD2GNA4V	LITHIUM CARBONATE CAPSULE, GELATIN COATED [TYA PHARMACEUTICALS]	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

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 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	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

Lithium Carbonate

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#