METOPROLOL TARTRATE

Product NDC: 68071-3942
11-digit product format: 680713942
Labeler code: 68071
Product ID: 68071-3942_47d11563-2d6a-623f-e063-6294a90a54c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METOPROLOL
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA202871
Marketing category: ANDA
Marketing start: 2016-07-31
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 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202871-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28
A202871-002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28
A202871-003	METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202871-001	AB
A202871-002	AB
A202871-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202871-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	2013-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202871-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	2013-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202871-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB	2013-05-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202871-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202871-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202871-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202871-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202871-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202871-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202871-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202871-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202871-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202871-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202871-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202871-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202871-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202871-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202871-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202871-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202871-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202871-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202871-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202871-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202871-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202871-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202871-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202871-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202871-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202871-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202871-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202871-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202871-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202871-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202871-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202871-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202871-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202871-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202871-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202871-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202871-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202871-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202871-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202871-001	AB	1	`1e350fbaab3a…`

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
47d11c0c-82dd-33b1-e063-6394a90a6a97	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
95ced987-af5e-4bea-8119-4e7d4558d21b	Product name	2	20200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
9ab5a42a-e77d-486b-bb1f-b343fe664ada	Product name	1	20180430
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
310125de-e7c0-730d-d178-98b990a0334a	Product name	2	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3942-3	METOPROLOL TARTRATE	30 in 1 BOTTLE	TABLET	30		1

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METOPROLOL TARTRATE	METOPROLOL	REMEDYREPACK INC.	58d493d3-b69c-422a-b6a8-0f8fa1e55545	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871
METOPROLOL TARTRATE	METOPROLOL	Bryant Ranch Prepack	00940cc5-d2eb-4841-9138-de97d7b1c674	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871
METOPROLOL TARTRATE	METOPROLOL	Northwind Health Company, LLC	471ccbfe-96dd-7ab9-e063-6394a90a5bd6	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871
METOPROLOL TARTRATE	METOPROLOL	REMEDYREPACK INC.	e1c99d45-8f42-46b1-b770-14d0eb2b300a	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871
METOPROLOL TARTRATE	METOPROLOL	Coupler LLC	512711ea-a3be-6de6-e063-6394a90a9109	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871
METOPROLOL TARTRATE	METOPROLOL	Proficient Rx LP	95b95aab-0733-4189-b4c0-429a1046c534	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871
METOPROLOL TARTRATE	METOPROLOL	NuCare Pharmaceuticals, Inc.	47d11c0c-82dd-33b1-e063-6394a90a6a97	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871 ndc (product): 68071-3942
METOPROLOL TARTRATE	METOPROLOL	Northwind Health Company, LLC	106b7a0c-af7f-2565-e063-6294a90a34e0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871
METOPROLOL TARTRATE	METOPROLOL	NCS HealthCare of KY, LLC dba Vangard Labs	c97e7527-b44e-48ca-b6be-53999bf5554b	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871
METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Inc.	24837d82-0f3f-4482-9af0-31e5f675c30f	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871
METOPROLOL TARTRATE	METOPROLOL	Alembic Pharmaceuticals Limited	cb76a73f-549a-4170-b96a-f93ed7e09464	2023-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202871 application number: ANDA202871

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W5S57Y3A5L	METOPROLOL TARTRATE	56392-17-7	METOPROLOL TARTRATE
GEB06NHM23	METOPROLOL	51384-51-1	METOPROLOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866511	metoprolol tartrate 100 MG Oral Tablet	PSN	47d11c0c-82dd-33b1-e063-6394a90a6a97	1
866511	metoprolol tartrate 100 MG Oral Tablet	SCD	47d11c0c-82dd-33b1-e063-6394a90a6a97	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3942-3	68071394203	30 TABLET in 1 BOTTLE (68071-3942-3)	30 tablet	2026-01-07	No	No	Current