Metoprolol succinate

Product NDC: 71335-0167
11-digit product format: 713350167
Labeler code: 71335
Product ID: 71335-0167_48bd6b90-f68e-4a25-8c68-907c0376c3ea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoprolol succinate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078889
Marketing category: ANDA
Marketing start: 2012-09-10
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: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	71335-0167		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	71335-0167	71335-0167-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	71335-0167	71335-0167-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	71335-0167	71335-0167-5	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	71335-0167	71335-0167-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	71335-0167	71335-0167-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	71335-0167	71335-0167-6	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	71335-0167		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	71335-0167	71335-0167-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	71335-0167	71335-0167-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	71335-0167	71335-0167-5	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	71335-0167	71335-0167-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	71335-0167	71335-0167-4	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	71335-0167	71335-0167-6	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

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…`

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 ndc (product): 71335-0167
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

Additional Listing Data#

Finished product: Yes
Brand name base: Metoprolol succinate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METOPROLOL SUCCINATE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TH25PD4CCB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866412	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
5d553160-7fcb-413a-8775-c128a1844977	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fac0d979-ed64-4395-be9a-fc0b6f8c0a4f	Product name	1	20260122
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
07ea0487-5434-6896-2497-013a7ee4afbd	Product name	9	20250311
95ced987-af5e-4bea-8119-4e7d4558d21b	Product name	2	20200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
9ab5a42a-e77d-486b-bb1f-b343fe664ada	Product name	1	20180430
310125de-e7c0-730d-d178-98b990a0334a	Product name	2	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71335-0167-1	2021-06-11	C162847	48780-1	9d75b9cf-ebb5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS . METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
71335-0167-2	2021-06-11	C162847	48780-1	9d75b9cf-ebb5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS . METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
71335-0167-3	2021-06-11	C162847	48780-1	9d75b9cf-ebb5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS . METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
71335-0167-4	2021-06-11	C162847	48780-1	9d75b9cf-ebb5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS . METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
71335-0167-5	2021-06-11	C162847	48780-1	9d75b9cf-ebb5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS . METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
71335-0167-6	2021-06-11	C162847	48780-1	9d75b9cf-ebb5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS . METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
71335-0167-1	2020-01-31	C162847	48780-1	9d75b9cf-ebb5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS . METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
71335-0167-2	2020-01-31	C162847	48780-1	9d75b9cf-ebb5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS . METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
71335-0167-3	2020-01-31	C162847	48780-1	9d75b9cf-ebb5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS . METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
71335-0167-4	2020-01-31	C162847	48780-1	9d75b9cf-ebb5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS . METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
71335-0167-5	2020-01-31	C162847	48780-1	9d75b9cf-ebb5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS . METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
71335-0167-6	2020-01-31	C162847	48780-1	9d75b9cf-ebb5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS . METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0167-1	Metoprolol succinate	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	6
71335-0167-2	Metoprolol succinate	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	6
71335-0167-3	Metoprolol succinate	120 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	120	6
71335-0167-4	Metoprolol succinate	20 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	20	6
71335-0167-5	Metoprolol succinate	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	6
71335-0167-6	Metoprolol succinate	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	6
71335-0167-7	Metoprolol succinate	10 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	10	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0167-1	EA - Each	71335-0167	a7277842-b2ff-4312-8d33-bf34ec8d569d	1	2018-03-08
71335-0167-2	EA - Each	71335-0167	390d2b20-b7a5-4a01-9e13-c927adf6c44c	1	2018-03-08
71335-0167-3	EA - Each	71335-0167	984eccc0-5e48-4a12-baf9-9fdb39af4373	1	2018-03-08
71335-0167-4	EA - Each	71335-0167	2b1b32a4-ef54-4222-ac76-ba0767e293ac	1	2018-03-08
71335-0167-5	EA - Each	71335-0167	05dd1c69-b1e2-477a-953f-35c447a39100	1	2018-03-08
71335-0167-6	EA - Each	71335-0167	c7643fc7-073f-4652-bd3d-d3e22718ba35	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0167	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	5	Current NDC, Legacy NDC, 7 package rows	20231110_5d553160-7fcb-413a-8775-c128a1844977.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866412	metoprolol succinate 100 MG 24HR Extended Release Oral Tablet	PSN	5d553160-7fcb-413a-8775-c128a1844977	6
866412	24 HR metoprolol succinate 100 MG Extended Release Oral Tablet	SCD	5d553160-7fcb-413a-8775-c128a1844977	6
866412	24 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral Tablet	SY	5d553160-7fcb-413a-8775-c128a1844977	6
866412	metoprolol succinate 100 MG 24 HR Extended Release Oral Tablet	SY	5d553160-7fcb-413a-8775-c128a1844977	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0167-1	71335016701	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0167-1)	2018-02-12	0000-00-00	No	No	Current
71335-0167-2	71335016702	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0167-2)	2018-02-16	0000-00-00	No	No	Current
71335-0167-3	71335016703	120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0167-3)	2018-02-14	0000-00-00	No	No	Current
71335-0167-4	71335016704	20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0167-4)	2022-05-02	0000-00-00	No	No	Current
71335-0167-5	71335016705	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0167-5)	2022-05-02	0000-00-00	No	No	Current
71335-0167-6	71335016706	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0167-6)	2022-05-02	0000-00-00	No	No	Current
71335-0167-7	71335016707	10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0167-7)	2022-05-02	0000-00-00	No	No	Current