Application 079139

Type: ANDA
Sponsor: GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LITHIUM CARBONATE	LITHIUM CARBONATE	CAPSULE;ORAL	150MG	No	No
002	LITHIUM CARBONATE	LITHIUM CARBONATE	CAPSULE;ORAL	300MG	No	No
003	LITHIUM CARBONATE	LITHIUM CARBONATE	CAPSULE;ORAL	600MG	No	No

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	Approval date
A079139-001	LITHIUM CARBONATE	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03
A079139-002	LITHIUM CARBONATE	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03
A079139-003	LITHIUM CARBONATE	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A079139-001	AB
A079139-002	AB
A079139-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079139-002	LITHIUM CARBONATE	300MG	CAPSULE / ORAL	AB	2009-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079139-003	LITHIUM CARBONATE	600MG	CAPSULE / ORAL	AB	2009-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079139-001	LITHIUM CARBONATE	150MG	CAPSULE / ORAL	AB	2009-02-03	`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	A079139-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079139-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079139-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079139-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079139-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079139-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079139-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079139-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079139-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079139-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079139-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079139-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079139-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079139-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079139-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079139-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079139-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079139-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079139-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079139-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079139-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079139-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079139-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079139-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079139-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079139-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079139-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079139-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079139-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079139-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079139-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079139-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079139-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079139-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079139-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079139-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079139-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079139-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079139-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079139-001	AB	1	`8072bd15b7f6…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	803eab29-0d0a-4df0-b504-bcd85ec01ead	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139 ndc (product): 70518-2312
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	1c320bff-b4d5-42f2-b2b5-238564fe9589	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139 ndc (product): 70518-0668
Lithium Carbonate	LITHIUM CARBONATE	Bryant Ranch Prepack	1a62d5ae-a4a3-4b10-8281-feba134bbe3a	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139 ndc (product): 71335-1006
Lithium Carbonate	LITHIUM CARBONATE	American Health Packaging	049902a9-3af1-4863-994e-15f36e7a9793	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139
Lithium Carbonate	LITHIUM CARBONATE	Coupler LLC	5102eb69-4872-53fb-e063-6394a90a8275	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139
Lithium Carbonate	LITHIUM CARBONATE	REMEDYREPACK INC.	57faf0b0-4380-4bbf-8de7-c3f9d74fc410	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139 ndc (product): 70518-3565
Lithium Carbonate	LITHIUM CARBONATE	Glenmark Pharmaceuticals Inc., USA	63b3790f-a9b5-47f4-bae1-ddf8b43c13c1	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139 ndc (product): 68462-221 ndc (product): 68462-222 ndc (product): 68462-220
Lithium Carbonate	LITHIUM CARBONATE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	203386e3-718f-7c84-e063-6394a90aed34	2024-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139
Lithium Carbonate	LITHIUM CARBONATE	NCS HealthCare of KY, LLC dba Vangard Labs	204d94de-83e4-400e-bd6b-70b49813802c	2023-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079139 application number: ANDA079139

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53808-0704	Lithium Carbonate	Lithium Carbonate	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0884	Lithium Carbonate	Lithium Carbonate	State of Florida DOH Central Pharmacy	ANDA	Current
63629-7730	Lithium Carbonate	Lithium Carbonate	Bryant Ranch Prepack	ANDA	Current
63629-7730	Lithium Carbonate	Lithium Carbonate	Bryant Ranch Prepack	ANDA	Current
68071-2714	Lithium Carbonate	Lithium Carbonate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68462-220	Lithium Carbonate	Lithium Carbonate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-220	Lithium Carbonate	Lithium Carbonate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-220	Lithium Carbonate	Lithium Carbonate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-220	Lithium Carbonate	Lithium Carbonate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-221	Lithium Carbonate	Lithium Carbonate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-221	Lithium Carbonate	Lithium Carbonate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-221	Lithium Carbonate	Lithium Carbonate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-221	Lithium Carbonate	Lithium Carbonate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-222	Lithium Carbonate	Lithium Carbonate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-222	Lithium Carbonate	Lithium Carbonate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-222	Lithium Carbonate	Lithium Carbonate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-222	Lithium Carbonate	Lithium Carbonate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68788-7164	Lithium Carbonate	Lithium Carbonate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7164	Lithium Carbonate	Lithium Carbonate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7164	Lithium Carbonate	Lithium Carbonate	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0668	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	ANDA	Current
70518-0668	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	ANDA	Current
70518-0668	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	ANDA	Current
70518-0668	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	ANDA	Current
70518-2312	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	ANDA	Current
70518-2312	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	ANDA	Current
70518-2312	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	ANDA	Current
70518-3565	Lithium Carbonate	Lithium Carbonate	REMEDYREPACK INC.	ANDA	Current
71335-1006	Lithium Carbonate	Lithium Carbonate	Bryant Ranch Prepack	ANDA	Current
71335-1006	Lithium Carbonate	Lithium Carbonate	Bryant Ranch Prepack	ANDA	Current
71335-1006	Lithium Carbonate	Lithium Carbonate	Bryant Ranch Prepack	ANDA	Current