LITHOBID

Product NDC: 62559-280
11-digit product format: 625590280
Labeler code: 62559
Product ID: 62559-280_75db0302-4a60-4b41-85fa-99ff2761ce56
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lithium carbonate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: NDA018027
Marketing category: NDA
Marketing start: 2014-07-01
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 42.

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
N018027-001	LITHOBID	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018027-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018027-001	LITHOBID	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N018027-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018027-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018027-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018027-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018027-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018027-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018027-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018027-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018027-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018027-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018027-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018027-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018027-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018027-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018027-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018027-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018027-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018027-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018027-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018027-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018027-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018027-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018027-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018027-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018027-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018027-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018027-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018027-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018027-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018027-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018027-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018027-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018027-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018027-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018027-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018027-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018027-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018027-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018027-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018027-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: LITHOBID
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197891	Internal RxNorm lookup
206786	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
f7f5b69a-c2a1-4586-a189-1475d41387c0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3053bb1-353b-4a0b-bca5-28fe7228957c	Product name	2	20250124
8ce6e144-236f-b7be-f690-f06e0c8c6bd3	Product name	2	20170725
f09af6ee-c6dd-d0ce-77ad-93508bcdaced	Product name	4	20161205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62559-280-01	LITHOBID	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62559-280-01	EA - Each	62559-280	21a0c71d-da62-43a8-8600-ad1f5086d74d	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lithium carbonate	ACTIVE INGREDIENT	2BMD2GNA4V	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	1
Lithium cation	ACTIVE MOIETY	8H8Z5UER66	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	1
calcium stearate	INACTIVE INGREDIENT	776XM7047L	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	1
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	1
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	1
Hypromellose 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	1
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62559-280	LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	12	Current NDC, Legacy NDC, 1 package rows	20221029_f7f5b69a-c2a1-4586-a189-1475d41387c0.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LITHOBID	LITHIUM CARBONATE	ANI Pharmaceuticals, Inc.	f7f5b69a-c2a1-4586-a189-1475d41387c0	2026-08-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018027 application number: NDA018027 ndc (product): 62559-280

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	f7f5b69a-c2a1-4586-a189-1475d41387c0	12
206786	LITHOBID 300 MG Extended Release Oral Tablet	PSN	f7f5b69a-c2a1-4586-a189-1475d41387c0	12
206786	lithium carbonate 300 MG Extended Release Oral Tablet [Lithobid]	SBD	f7f5b69a-c2a1-4586-a189-1475d41387c0	12
197891	lithium carbonate 300 MG Extended Release Oral Tablet	SCD	f7f5b69a-c2a1-4586-a189-1475d41387c0	12
197891	LiCO3 300 MG Extended Release Oral Tablet	SY	f7f5b69a-c2a1-4586-a189-1475d41387c0	12
206786	LiCO3 300 MG Extended Release Oral Tablet [Lithobid]	SY	f7f5b69a-c2a1-4586-a189-1475d41387c0	12
206786	Lithobid 300 MG Extended Release Oral Tablet	SY	f7f5b69a-c2a1-4586-a189-1475d41387c0	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62559-280-01	62559028001	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62559-280-01)	2014-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LITHOBID ® (Lithium Carbonate USP) Extended-Release Tablets 300 mg	ANI Pharmaceuticals, Inc.	2026-08-24	HUMAN PRESCRIPTION DRUG LABEL	13