Metoprolol succinate

Product NDC: 68645-479
Requested package NDC: 68645-479-54
11-digit product format: 686450479
Labeler code: 68645
Product ID: 68645-479_dad32c42-7878-2e23-e053-2a95a90ab6ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoprolol succinate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Legacy Pharmaceutical Packaging, LLC
Application: ANDA078889
Marketing category: ANDA
Marketing start: 2012-09-10
Marketing end: 0000-00-00
Substance: METOPROLOL SUCCINATE
Active strength: 100 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68645-479	68645-479-54	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078889-001	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB		2012-08-15
A078889-002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB		2012-08-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078889-001	AB
A078889-002	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 3 · 82 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	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078889-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078889-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-08-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078889-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078889-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078889-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078889-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078889-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078889-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078889-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078889-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078889-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078889-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078889-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078889-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078889-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078889-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078889-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078889-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078889-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078889-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078889-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078889-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078889-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078889-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078889-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078889-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078889-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078889-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078889-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078889-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078889-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078889-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078889-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078889-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078889-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078889-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078889-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078889-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078889-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078889-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078889-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078889-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68645-479-54	EA - Each	68645-479	ca16140e-4f3d-409c-abf0-09ef32d1fcde	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METOPROLOL SUCCINATE	ACTIVE INGREDIENT	TH25PD4CCB	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]	1
METOPROLOL	ACTIVE MOIETY	GEB06NHM23	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]	1
ACETYLTRIBUTYL CITRATE	INACTIVE INGREDIENT	0ZBX0N59RZ	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]	1
ETHYLCELLULOSE (10 MPA.S)	INACTIVE INGREDIENT	3DYK7UYZ62	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]	1
METHYLENE CHLORIDE	INACTIVE INGREDIENT	588X2YUY0A	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68645-479	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC]	9	Legacy NDC	20241016_3eed9ead-7076-4b18-9e36-8c66d50a06a1.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoprolol succinate	METOPROLOL SUCCINATE	Aphena Pharma Solutions - Tennessee, LLC	52bdc5cc-973f-4af6-e063-6294a90aba22	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol Succinate	METOPROLOL SUCCINATE	Cardinal Health 107, LLC	450fb603-73d7-422b-a4e2-5a05c13ebe3b	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	7689f30e-4010-4d7f-b450-9bc181259495	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	860e0ee0-b24f-4eff-b196-b9b03b37d3d5	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	Dr. Reddy's Laboratories Inc	5b7095c8-f8b7-adc7-9052-92325da33a02	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	REMEDYREPACK INC.	d971e541-3988-4834-baa2-236133ee106f	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	PD-Rx Pharmaceuticals, Inc.	189b6a89-8de8-4a62-a54b-a6c52be870ca	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	Bryant Ranch Prepack	5d553160-7fcb-413a-8775-c128a1844977	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	AvPAK	71b27b55-44aa-113d-e053-2995a90a1cf7	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	Cardinal Health 107, LLC	184db12c-0642-4741-a997-cd0b2a5ce337	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	Major Pharmaceuticals	459fe5ce-14d1-4901-956a-b5597ea9016c	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	Dr. Reddy's Laboratories Limited	71c1d33e-be6f-6d59-b715-45075445891a	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	Quallent Pharmaceuticals Health LLC	e147a897-4a23-1e1a-73cd-f2e6c9a7280d	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	Northstar Rx LLC	d887be8a-e6c2-5129-edbd-d7b2c0283dca	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	REMEDYREPACK INC.	35304060-0965-488d-9e6e-bd1217286ea1	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	NCS HealthCare of KY, LLC dba Vangard Labs	53613463-d5b6-41e7-aa43-1b75633c61fd	2024-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol Succinate	METOPROLOL SUCCINATE	American Health Packaging	74e3b4dc-eb30-4d7c-a558-cf58f6470496	2024-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	A-S Medication Solutions	aa1c7d31-78be-465f-9564-03685a58add8	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
Metoprolol succinate	METOPROLOL SUCCINATE	A-S Medication Solutions	f09d07f1-e0d1-444d-8e8a-f340f7377c8d	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Direct_Rx	90a69a79-5517-0ccf-e053-2995a90a441f	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078889 application number: ANDA078889

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TH25PD4CCB	METOPROLOL SUCCINATE	98418-47-4	METOPROLOL SUCCINATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68645-479-54	68645047954	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68645-479-54)	2012-09-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metoprolol succinate	Legacy Pharmaceutical Packaging, LLC	2024-10-14	HUMAN PRESCRIPTION DRUG LABEL	9