Metoprolol Tartrate

Product NDC: 72789-583
Requested package NDC: 72789-583-60
11-digit product format: 727890583
Labeler code: 72789
Product ID: 72789-583_58508de9-da5e-93b9-e063-6294a90a924e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metoprolol tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA076704
Marketing category: ANDA
Marketing start: 1993-12-23
Substance: METOPROLOL TARTRATE
Active strength: 50 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA]; beta-Adrenergic Blocker [EPC]
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

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	RLD / RS	Approval date
A076704-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16
A076704-002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16
A076704-003	METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16
A076704-004	METOPROLOL TARTRATE	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18
A076704-005	METOPROLOL TARTRATE	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076704-001	AB
A076704-002	AB
A076704-003	AB
A076704-004	AB
A076704-005	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 · 205 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
2026-02-19 14:30 UTC	2026-02	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 201 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	A076704-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076704-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-005	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metoprolol Tartrate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METOPROLOL TARTRATE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W5S57Y3A5L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866514	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
cbcec1e7-7eac-456e-a253-aaf6761b4883	Available on FDA.report

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	cbcec1e7-7eac-456e-a253-aaf6761b4883	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704 ndc (package): 72789-583-60 ndc (product): 72789-583 ndc11 (package): 72789058360
Metoprolol Tartrate	METOPROLOL TARTRATE	Cardinal Health 107, LLC	0ccb9d3c-3f9a-486d-9b27-dc6f3ef6f4ed	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704
Metoprolol Tartrate	METOPROLOL TARTRATE	Safecor Health, LLC	63d45147-9b37-40e2-9619-cd1a3e77ff31	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	ab44f4c5-9497-4c92-8545-e4718ddb8f08	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704
Metoprolol Tartrate	METOPROLOL TARTRATE	Mylan Institutional Inc.	961248d5-d53c-408d-8f8f-d31885054f96	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704
Metoprolol Tartrate	METOPROLOL TARTRATE	Cardinal Health 107, LLC	6399f2c3-7799-4f8b-b8b7-8d2137b1f852	2025-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704
Metoprolol Tartrate	METOPROLOL TARTRATE	Golden State Medical Supply, Inc.	bec7ccad-00ad-4a3b-e053-2995a90ae3d8	2024-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704
Metoprolol Tartrate	METOPROLOL TARTRATE	Mylan Pharmaceuticals Inc.	809c6386-0039-42ff-a03e-e42733e229b8	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704
Metoprolol Tartrate	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	ea141b60-b08e-4f0f-9f29-cd765f4d7ca6	2022-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704

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	Sample	Status
72789-583-60	72789058360	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-583-60)	2026-07-28	0	Current