Metoprolol Tartrate

Product NDC: 71610-158
11-digit product format: 716100158
Labeler code: 71610
Product ID: 71610-158_35ed395e-7b5c-4f66-ab20-28e5b04501f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoprolol Tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA200981
Marketing category: ANDA
Marketing start: 2015-08-14
Marketing end: 0000-00-00
Substance: METOPROLOL TARTRATE
Active strength: 50 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71610-158		D	Discontinued by firm	2026-10-15
excluded package	package	71610-158	71610-158-60	D	Discontinued by firm	2026-10-15
excluded package	package	71610-158	71610-158-80	D	Discontinued by firm	2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A200981-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28
A200981-002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28
A200981-003	METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28
A200981-004	METOPROLOL TARTRATE	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21
A200981-005	METOPROLOL TARTRATE	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A200981-001	AB
A200981-002	AB
A200981-003	AB
A200981-004	AB
A200981-005	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 6 · 216 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
2026-10-15 13:18:30	2026-09	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 216 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A200981-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200981-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200981-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200981-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200981-005	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A200981-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200981-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200981-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200981-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200981-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200981-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200981-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200981-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200981-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200981-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200981-005	AB	1	`b8a1b40f171c…`

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
71610-158-60	EA - Each	71610-158	651aa3e4-5d4f-4be0-bab1-568e4919240c	1	2018-12-13
71610-158-80	EA - Each	71610-158	dcf3df60-591b-40d2-aeb5-5aa895b989a0	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-158	METOPROLOL TARTRATE (METOPROLOL TARTRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20181019_837c447f-bee9-4773-9850-cdbdf6c6c046.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 5 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoprolol Tartrate	METOPROLOL TARTRATE	NuCare Pharmaceuticals,Inc.	87ef9aa6-2faa-0f77-e053-2a95a90a3a26	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
Metoprolol Tartrate	METOPROLOL TARTRATE	Bryant Ranch Prepack	7e9e5e82-10fa-4e9b-b57c-3ec85b05c046	2019-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W5S57Y3A5L	METOPROLOL TARTRATE	56392-17-7	METOPROLOL TARTRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-158-60	71610015860	90 TABLET, FILM COATED in 1 BOTTLE (71610-158-60)	2018-09-21	0000-00-00	No	No	Current
71610-158-80	71610015880	180 TABLET, FILM COATED in 1 BOTTLE (71610-158-80)	2018-09-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METOPROLOL TARTRATE - metoprolol tartrate tablet, film coated Vensun Pharmaceuticals, Inc. R x only	Aphena Pharma Solutions - Tennessee, LLC	2018-10-16	HUMAN PRESCRIPTION DRUG LABEL	1