METOPROLOL SUCCINATE

Product NDC: 67046-1686
Requested package NDC: 67046-1686-3
11-digit product format: 670461686
Labeler code: 67046
Product ID: 67046-1686_55f20c3a-009f-ee3e-e063-6294a90aaee0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metoprolol succinate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA207465
Marketing category: ANDA
Marketing start: 2026-07-06
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: 2027-12-31
Current FDA listing: Yes

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

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
A207465-001	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26
A207465-002	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26
A207465-003	METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207465-001	AB
A207465-002	AB
A207465-003	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 · 129 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	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207465-002	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207465-003	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207465-001	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A207465-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207465-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207465-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207465-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207465-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207465-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207465-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207465-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207465-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207465-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207465-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207465-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207465-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207465-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207465-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207465-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207465-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207465-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207465-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207465-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207465-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207465-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207465-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207465-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207465-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207465-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207465-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207465-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207465-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207465-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207465-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207465-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207465-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207465-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207465-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207465-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207465-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207465-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207465-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207465-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: METOPROLOL SUCCINATE
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TH25PD4CCB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866412	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
55f20cc3-d958-bd74-e063-6394a90a7850	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Coupler LLC	55f20cc3-d958-bd74-e063-6394a90a7850	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465 ndc (package): 67046-1686-3 ndc (product): 67046-1686 ndc11 (package): 67046168603
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Preferred Pharmaceuticals Inc.	7dfe56fe-68b6-4897-9238-0f530c92e27e	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	NuCare Pharmaceuticals,Inc.	a849d489-8f8c-18e6-e053-2995a90a3770	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	A-S Medication Solutions	91e401fe-ec92-494e-9966-35c280f23efa	2023-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	A-S Medication Solutions	820a962a-5b15-4beb-bd78-e1ac10cb2e0e	2023-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	BluePoint Laboratories	6a4f2446-a9e4-479a-87bd-2d5539dcded9	2023-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Bryant Ranch Prepack	5bf27a6c-ea3f-425e-9cfc-a5a308e2af1c	2023-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Cipla USA Inc.	3a4966a2-2728-4c99-999f-576b3e2df90c	2023-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207465 application number: ANDA207465

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67046-1686-3	67046168603	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1686-3)	2026-07-06	No	No	Current