Application 018558

Type: NDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LITHIUM CARBONATE	LITHIUM CARBONATE	TABLET;ORAL	300MG	Yes	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
N018558-001	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	TABLET / ORAL		RLD, RS	1982-01-29

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL		RLD, RS	1982-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018558-001	LITHIUM CARBONATE	300MG	TABLET / ORAL	AB	RLD, RS	1982-01-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N018558-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018558-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018558-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018558-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018558-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018558-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018558-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018558-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018558-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018558-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018558-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018558-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018558-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018558-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018558-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018558-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018558-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018558-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018558-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018558-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018558-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018558-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018558-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018558-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018558-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018558-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018558-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018558-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018558-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018558-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018558-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018558-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018558-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018558-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018558-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018558-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018558-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018558-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018558-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018558-001	AB	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	c84cce95-cfcb-4426-aac6-d2f48f946ada	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018558 application number: NDA018558
Lithium Carbonate	LITHIUM CARBONATE	PD-Rx Pharmaceuticals, Inc.	d20ed2aa-aa56-4709-9e7a-9243c71465c9	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018558 application number: NDA018558 ndc (product): 72789-174
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): 018558 application number: NDA018558 ndc (product): 0054-8528 ndc (product): 0054-4527

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-4527	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-4527	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-4527	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-4527	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-4527	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-4527	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-4527	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-4527	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8528	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8528	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8528	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8528	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0054-8528	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8528	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8528	Lithium Carbonate	Lithium Carbonate	West-Ward Pharmaceuticals Corp	NDA	Current
0054-8528	Lithium Carbonate	Lithium Carbonate	Hikma Pharmaceuticals USA Inc.	NDA	Current
70518-0150	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	NDA	Current
72789-174	Lithium Carbonate	Lithium Carbonate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
72789-174	Lithium Carbonate	Lithium Carbonate	PD-Rx Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72387	SUPPL	2022-10-17
72386	SUPPL	2022-10-17
72342	SUPPL	2022-10-14
61837	SUPPL	2020-02-06
61836	SUPPL	2020-02-06
61784	SUPPL	2020-02-06
57000	SUPPL	2018-12-21
56999	SUPPL	2018-12-21
56957	SUPPL	2018-12-21
55920	SUPPL	2018-10-15
55919	SUPPL	2018-10-15
55891	SUPPL	2018-10-11
45758	SUPPL	2016-11-01
45711	SUPPL	2016-10-28