Application 078459

Type: ANDA
Sponsor: IPCA LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	25MG	No	No
002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	50MG	No	No
003	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	100MG	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
A078459-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17
A078459-002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17
A078459-003	METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078459-001	AB
A078459-002	AB
A078459-003	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	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078459-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2008-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078459-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2008-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078459-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2008-06-17	`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	A078459-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078459-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078459-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078459-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078459-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078459-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078459-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078459-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078459-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078459-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078459-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078459-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078459-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078459-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078459-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078459-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078459-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078459-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078459-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078459-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078459-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078459-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078459-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078459-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078459-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078459-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078459-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078459-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078459-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078459-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078459-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078459-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078459-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078459-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078459-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078459-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078459-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078459-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078459-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078459-001	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 9 · 168 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoprolol Tartrate	METOPROLOL TARTRATE	REMEDYREPACK INC.	c9ccdbc0-0e4e-40c4-aacf-de60deda9fd5	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	REMEDYREPACK INC.	3a236293-35c1-4083-9805-ab40df535083	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	cbcec1e7-7eac-456e-a253-aaf6761b4883	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL	REMEDYREPACK INC.	58d493d3-b69c-422a-b6a8-0f8fa1e55545	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	58239cf1-53b4-4ef7-e063-6394a90a65bd	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Cardinal Health 107, LLC	6399f2c3-7799-4f8b-b8b7-8d2137b1f852	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	REMEDYREPACK INC.	028b6e4a-1597-4d21-89d0-0bbbad21efa8	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL	Bryant Ranch Prepack	00940cc5-d2eb-4841-9138-de97d7b1c674	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL	Northwind Health Company, LLC	471ccbfe-96dd-7ab9-e063-6394a90a5bd6	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	5476c4fc-ab09-ee1a-e063-6394a90a7a1b	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Cardinal Health 107, LLC	0ccb9d3c-3f9a-486d-9b27-dc6f3ef6f4ed	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Safecor Health, LLC	63d45147-9b37-40e2-9619-cd1a3e77ff31	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Bryant Ranch Prepack	a590edb1-3310-49e3-b3d1-dbbb3f81f1c1	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	American Health Packaging	0a3ccfd4-8b65-4c7e-b0ba-27ff40d5b5e8	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	St. Mary's Medical Park Pharmacy	3bc7d371-6057-a9dc-e063-6394a90a6a9c	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Preferred Pharmaceuticals Inc.	5fd16fbd-be05-49aa-86a9-0f775c1b5a37	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Preferred Pharmaceuticals Inc.	9af11192-61fa-44b8-86eb-3a5e68ec1747	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Preferred Pharmaceuticals, Inc.	b4d1e5ba-f1a8-4c77-bd65-db8e9342370b	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL	REMEDYREPACK INC.	e1c99d45-8f42-46b1-b770-14d0eb2b300a	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	St. Mary's Medical Park Pharmacy	e3de73ee-bcc7-ba40-e053-2a95a90a8f8f	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50436-3155	Metoprolol Tartrate	Metoprolol Tartrate	Unit Dose Services	ANDA	Current
50436-6578	Metoprolol Tartrate	Metoprolol Tartrate	Unit Dose Services	ANDA	Current
53808-1018	Metoprolol Tartrate	Metoprolol Tartrate	State of Florida DOH Central Pharmacy	ANDA	Current
63304-579	Metoprolol Tartrate	Metoprolol Tartrate	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-580	Metoprolol Tartrate	Metoprolol Tartrate	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-581	Metoprolol Tartrate	Metoprolol Tartrate	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63629-1462	Metoprolol Tartrate	Metoprolol Tartrate	Bryant Ranch Prepack	ANDA	Current
64725-0579	Metoprolol Tartrate	Metoprolol Tartrate	TYA Pharmaceuticals	ANDA	Current
67046-473	Metoprolol tartrate	metoprolol tartrate	Contract Pharmacy Services-PA	ANDA	Current
67046-474	Metoprolol Tartrate	Metoprolol tartrate	Contract Pharmacy Services-PA	ANDA	Current
68788-9686	Metoprolol Tartrate	Metoprolol Tartrate	Preferred Pharmaceuticals, Inc.	ANDA	Current