Metoprolol Succinate

Product NDC: 75834-292
Requested package NDC: 75834-292-00
11-digit product format: 758340292
Labeler code: 75834
Product ID: 75834-292_01740be9-3731-2dd7-e063-6294a90a2b7a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoprolol Succinate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Nivagen Pharmaceuticals, Inc.
Application: ANDA203699
Marketing category: ANDA
Marketing start: 2021-02-26
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: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	75834-292	75834-292-00	D	Discontinued by firm		2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203699-001	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB		2020-03-30
A203699-002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB		2020-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203699-001	AB
A203699-002	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 2 · 78 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
2026-09-14 22:38:34	2026-08	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203699-001	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203699-002	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A203699-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203699-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203699-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203699-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203699-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203699-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203699-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203699-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203699-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203699-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203699-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203699-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203699-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203699-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203699-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203699-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203699-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203699-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203699-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203699-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203699-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203699-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203699-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203699-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203699-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203699-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203699-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203699-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203699-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203699-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203699-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203699-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203699-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203699-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203699-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203699-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203699-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203699-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203699-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203699-002	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: No
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METOPROLOL SUCCINATE	100 mg/1

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	SPL version
75834-292-00	Metoprolol Succinate	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	3
75834-292-01	Metoprolol Succinate	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	3
75834-292-05	Metoprolol Succinate	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75834-292-00	EA - Each	75834-292	04bfa3eb-1224-45aa-94ba-1a95bb559133	1	2022-05-04
75834-292-01	EA - Each	75834-292	1bb1343b-2980-4c42-9de9-7072827a8c4c	1	2022-05-04
75834-292-05	EA - Each	75834-292	44ab7b06-113e-4a2c-a519-41b1a9ed3827	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75834-292	METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NIVAGEN PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 3 package rows	20230805_da7a72f9-2246-6934-e053-2995a90a6376.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TH25PD4CCB	METOPROLOL SUCCINATE	98418-47-4	METOPROLOL SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866412	metoprolol succinate 100 MG 24HR Extended Release Oral Tablet	PSN	da7a72f9-2246-6934-e053-2995a90a6376	3
866419	metoprolol succinate 200 MG 24HR Extended Release Oral Tablet	PSN	da7a72f9-2246-6934-e053-2995a90a6376	3
866412	24 HR metoprolol succinate 100 MG Extended Release Oral Tablet	SCD	da7a72f9-2246-6934-e053-2995a90a6376	3
866419	24 HR metoprolol succinate 200 MG Extended Release Oral Tablet	SCD	da7a72f9-2246-6934-e053-2995a90a6376	3
866412	24 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral Tablet	SY	da7a72f9-2246-6934-e053-2995a90a6376	3
866419	24 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral Tablet	SY	da7a72f9-2246-6934-e053-2995a90a6376	3
866412	metoprolol succinate 100 MG 24 HR Extended Release Oral Tablet	SY	da7a72f9-2246-6934-e053-2995a90a6376	3
866419	metoprolol succinate 200 MG 24 HR Extended Release Oral Tablet	SY	da7a72f9-2246-6934-e053-2995a90a6376	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
75834-292-00	75834029200	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-292-00)	2022-02-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metoprolol Succinate	REMEDYREPACK INC.	2025-09-18	HUMAN PRESCRIPTION DRUG LABEL	6
Metoprolol Succinate	A-S Medication Solutions	2024-01-04	HUMAN PRESCRIPTION DRUG LABEL	3
Metoprolol Succinate	A-S Medication Solutions	2023-12-26	HUMAN PRESCRIPTION DRUG LABEL	1
Metoprolol Succinate	Nivagen Pharmaceuticals, Inc. \| Pharmadax Inc. \| CorePharma, LLC \| Pharmadax (Foshan) Co.,Ltd	2023-03-31	HUMAN PRESCRIPTION DRUG LABEL	3
Metoprolol Succinate	ST. MARY'S MEDICAL PARK PHARMACY	2022-06-22	HUMAN PRESCRIPTION DRUG LABEL	1