Lithium Carbonate

Product NDC: 46708-148
11-digit product format: 467080148
Labeler code: 46708
Product ID: 46708-148_fa1dd72f-c205-4377-881e-836882c4de47
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium Carbonate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA204445
Marketing category: ANDA
Marketing start: 2017-02-21
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
A204445-001	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL			2015-06-10

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	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204445-001	LITHIUM CARBONATE	300MG	TABLET, EXTENDED RELEASE / ORAL		2015-06-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204445-001	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A204445-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204445-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204445-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204445-001	AB	1	`ea99ee380514…`

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
8e950a50-689d-4bf8-87ce-cffd43c6d5c2	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
46708-148-08	2023-02-01	Lithium Carbonate Extended-Release Tablets USP, 300 mg 07/2016 Rx only
46708-148-30	2023-02-01	Lithium Carbonate Extended-Release Tablets USP, 300 mg 07/2016 Rx only
46708-148-31	2023-02-01	Lithium Carbonate Extended-Release Tablets USP, 300 mg 07/2016 Rx only
46708-148-91	2023-02-01	Lithium Carbonate Extended-Release Tablets USP, 300 mg 07/2016 Rx only
46708-148-08	2023-01-30	Lithium Carbonate Extended-Release Tablets USP, 300 mg 07/2016 Rx only
46708-148-30	2023-01-30	Lithium Carbonate Extended-Release Tablets USP, 300 mg 07/2016 Rx only
46708-148-31	2023-01-30	Lithium Carbonate Extended-Release Tablets USP, 300 mg 07/2016 Rx only
46708-148-91	2023-01-30	Lithium Carbonate Extended-Release Tablets USP, 300 mg 07/2016 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46708-148-08	Lithium Carbonate	80 in 1 CARTON	TABLET, EXTENDED RELEASE	80	5
46708-148-30	Lithium Carbonate	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	5
46708-148-31	Lithium Carbonate	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	5
46708-148-91	Lithium Carbonate	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-148	LITHIUM CARBONATE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	5	Current NDC, Legacy NDC, 4 package rows	20230202_8e950a50-689d-4bf8-87ce-cffd43c6d5c2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate	LITHIUM CARBONATE	Alembic Pharmaceuticals Inc.	a1e2f942-2bc0-4afd-91ad-6c4cab38c8f0	2024-12-12	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 204445 application number: ANDA204445
Lithium Carbonate	LITHIUM CARBONATE	Alembic Pharmaceuticals Limited	8e950a50-689d-4bf8-87ce-cffd43c6d5c2	2023-01-30	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 204445 application number: ANDA204445 ndc (product): 46708-148

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	8e950a50-689d-4bf8-87ce-cffd43c6d5c2	5
197891	lithium carbonate 300 MG Extended Release Oral Tablet	SCD	8e950a50-689d-4bf8-87ce-cffd43c6d5c2	5
197891	LiCO3 300 MG Extended Release Oral Tablet	SY	8e950a50-689d-4bf8-87ce-cffd43c6d5c2	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-148-08	46708014808	80 TABLET, EXTENDED RELEASE in 1 CARTON (46708-148-08)	2017-02-21	0000-00-00	No	No	Current
46708-148-30	46708014830	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-148-30)	2017-02-21	0000-00-00	No	No	Current
46708-148-31	46708014831	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-148-31)	2017-02-21	0000-00-00	No	No	Current
46708-148-91	46708014891	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-148-91)	2017-02-21	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 07/2016 Rx only	Alembic Pharmaceuticals Limited	2023-01-30	Human Prescription Drug Label	5