METOPROLOL SUCCINATE

Product NDC: 71610-483
11-digit product format: 716100483
Labeler code: 71610
Product ID: 71610-483_8d71968c-b273-4b5e-9afd-4f04e10c45cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoprolol succinate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA019962
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-01-01
Marketing end: 0000-00-00
Substance: METOPROLOL SUCCINATE
Active strength: 25 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71610-483		D	Discontinued by firm	2026-10-05
excluded package	package	71610-483	71610-483-45	D	Discontinued by firm	2026-10-05
excluded package	package	71610-483	71610-483-60	D	Discontinued by firm	2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019962-001	TOPROL-XL	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10
N019962-002	TOPROL-XL	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10
N019962-003	TOPROL-XL	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10
N019962-004	TOPROL-XL	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N019962-001	AB
N019962-002	AB
N019962-003	AB
N019962-004	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 5 · 172 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
2026-09-14 22:38:34	2026-08	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019962-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019962-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019962-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019962-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019962-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019962-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019962-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019962-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019962-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019962-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-483-45	METOPROLOL SUCCINATE	45 in 1 BOTTLE	TABLET, EXTENDED RELEASE	45		2
71610-483-60	METOPROLOL SUCCINATE	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-483-45	EA - Each	71610-483	7cdd02b4-c3b1-4734-afcf-1c132f7790d2	1	2021-02-05
71610-483-60	EA - Each	71610-483	2c9c696f-97c8-4611-a3f2-6f6f8a43c032	1	2021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-483	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 2 package rows	20201212_1b926135-a67f-4386-a2ba-de5d9fd5a7c5.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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOPROL XL	METOPROLOL SUCCINATE	Melinta Therapeutics, LLC	496ddfaa-7c9c-4888-b747-a210249b367a	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019962 application number: NDA019962
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Proficient Rx LP	e236f1ed-b400-4854-81c7-64964422a2f7	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019962 application number: NDA019962
TOPROL XL	METOPROLOL SUCCINATE	Aphena Pharma Solutions - Tennessee, LLC	a07891a5-152e-4a38-8179-e05a90458a7d	2018-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019962 application number: NDA019962

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	1b926135-a67f-4386-a2ba-de5d9fd5a7c5	2
866427	metoprolol succinate 25 MG 24HR Extended Release Oral Tablet	PSN	1b926135-a67f-4386-a2ba-de5d9fd5a7c5	2
866412	24 HR metoprolol succinate 100 MG Extended Release Oral Tablet	SCD	1b926135-a67f-4386-a2ba-de5d9fd5a7c5	2
866427	24 HR metoprolol succinate 25 MG Extended Release Oral Tablet	SCD	1b926135-a67f-4386-a2ba-de5d9fd5a7c5	2
866412	24 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral Tablet	SY	1b926135-a67f-4386-a2ba-de5d9fd5a7c5	2
866427	24 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral Tablet	SY	1b926135-a67f-4386-a2ba-de5d9fd5a7c5	2
866412	metoprolol succinate 100 MG 24 HR Extended Release Oral Tablet	SY	1b926135-a67f-4386-a2ba-de5d9fd5a7c5	2
866427	metoprolol succinate 25 MG 24 HR Extended Release Oral Tablet	SY	1b926135-a67f-4386-a2ba-de5d9fd5a7c5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-483-45	71610048345	45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-483-45)	2020-11-10	0000-00-00	No	No	Current
71610-483-60	71610048360	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-483-60)	2020-11-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METOPROLOL SUCCINATE	Aphena Pharma Solutions - Tennessee, LLC	2026-01-28	HUMAN PRESCRIPTION DRUG LABEL	2