Metoprolol Tartrate

Product NDC: 72189-659
11-digit product format: 721890659
Labeler code: 72189
Product ID: 72189-659_499ce022-12a8-e4e5-e063-6394a90a435a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoprolol Tartrate
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA200981
Marketing category: ANDA
Marketing start: 2026-01-30
Substance: METOPROLOL TARTRATE
Active strength: 100 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A200981-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2014-10-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A200981-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2014-10-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A200981-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2014-10-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A200981-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB	2019-08-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A200981-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB	2019-08-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A200981-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A200981-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A200981-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A200981-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A200981-005	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	5476c4fc-ab09-ee1a-e063-6394a90a7a1b	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
Metoprolol Tartrate	METOPROLOL TARTRATE	Bryant Ranch Prepack	a590edb1-3310-49e3-b3d1-dbbb3f81f1c1	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	St. Mary's Medical Park Pharmacy	3bc7d371-6057-a9dc-e063-6394a90a6a9c	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
Metoprolol Tartrate	METOPROLOL TARTRATE	Preferred Pharmaceuticals Inc.	5fd16fbd-be05-49aa-86a9-0f775c1b5a37	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
Metoprolol Tartrate	METOPROLOL TARTRATE	Preferred Pharmaceuticals Inc.	9af11192-61fa-44b8-86eb-3a5e68ec1747	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
Metoprolol Tartrate	METOPROLOL TARTRATE	Preferred Pharmaceuticals, Inc.	b4d1e5ba-f1a8-4c77-bd65-db8e9342370b	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
Metoprolol Tartrate	METOPROLOL TARTRATE	St. Mary's Medical Park Pharmacy	e3de73ee-bcc7-ba40-e053-2a95a90a8f8f	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
Metoprolol Tartrate	METOPROLOL TARTRATE	Preferred Pharmaceuticals Inc.	35922e9c-6a4c-446a-8294-a4cd3f3f0d10	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	54754388-39c9-9a02-e063-6394a90a90b3	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	5466243e-1e3d-175e-e063-6394a90a5dee	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	fae7a662-9b27-4c5f-80b5-22442f0ae436	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	NuCare Pharmaceuticals,Inc.	485f1fdb-6543-4f47-e063-6394a90a2459	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	5987a15b-e86f-4fd7-a377-35a917c0e3fe	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
Metoprolol Tartrate	METOPROLOL TARTRATE	Direct_Rx	5371c1af-93fa-39db-e063-6394a90a6111	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	St. Mary's Medical Park Pharmacy	e55cd5b5-c739-24ba-e053-2995a90a3ed4	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	REMEDYREPACK INC.	f7a05d74-f5e9-4236-a967-c57942a2bbf3	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	522c3807-855e-20a3-e063-6394a90abeb7	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	522cc739-1252-4689-e063-6294a90ad1b0	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	A-S Medication Solutions	ef6a817b-58c5-45bc-b5a2-22c31b05c0ab	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981
METOPROLOL TARTRATE	METOPROLOL TARTRATE	A-S Medication Solutions	2bcfb9d9-e092-4a0a-ac55-bad532de360c	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200981 application number: ANDA200981

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	100 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
866511	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
499ce022-12a7-e4e5-e063-6394a90a435a	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-659-90	Metoprolol Tartrate	90 in 1 BOTTLE	TABLET	90		1

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866511	metoprolol tartrate 100 MG Oral Tablet	PSN	499ce022-12a7-e4e5-e063-6394a90a435a	1
866511	metoprolol tartrate 100 MG Oral Tablet	SCD	499ce022-12a7-e4e5-e063-6394a90a435a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-659-90	72189065990	90 TABLET in 1 BOTTLE (72189-659-90)	90 tablet	2026-01-30	No	No	Current