TOPROL

Product NDC: 71610-038
11-digit product format: 716100038
Labeler code: 71610
Product ID: 71610-038_c3184015-df82-4ed5-b174-4e858241622c
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
Marketing start: 2018-01-01
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: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71610-038		D	Discontinued by firm		2026-10-05
excluded package	package	71610-038	71610-038-60	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-038-60	EA - Each	71610-038	744254e1-c06a-4b88-b33b-c44b5a5518d9	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-038	TOPROL XL (METOPROLOL SUCCINATE) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20180301_1f4a2b92-29c0-4dac-b199-2e15fbd42d9a.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-038-60	71610003860	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-038-60)	2018-02-02	0000-00-00	No	No	Current