METOPROLOL SUCCINATE

Product NDC
70518-2868
11-digit product format
705182868
Labeler code
70518
Product ID
70518-2868_d774022c-ed50-8782-e053-2a95a90a1bd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207465
Marketing category
ANDA
Marketing start
2020-09-06
Marketing end
0000-00-00
Substance
METOPROLOL SUCCINATE
Active strength
50 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2868DDiscontinued by firm2026-08-10
excluded packagepackage70518-286870518-2868-0DDiscontinued by firm2026-08-10
excluded packagepackage70518-286870518-2868-1DDiscontinued by firm2026-08-10
excluded packagepackage70518-286870518-2868-2DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-2868-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-2868-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-2868-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2868-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2868-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2868-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2868-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2868-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2868-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2868-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2868-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2868-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2868-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2868-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2868-0557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207465-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26
A207465-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26
A207465-003METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207465-001AB
A207465-002AB
A207465-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207465-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207465-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207465-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207465-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207465-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207465-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A207465-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207465-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207465-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207465-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207465-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207465-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207465-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207465-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207465-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207465-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207465-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207465-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207465-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207465-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207465-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207465-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207465-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207465-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207465-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207465-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207465-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207465-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A207465-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A207465-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207465-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207465-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207465-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207465-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207465-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207465-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207465-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207465-002METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207465-003METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207465-001METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-10-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207465-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207465-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207465-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207465-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207465-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207465-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207465-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207465-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207465-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207465-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207465-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207465-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207465-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207465-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207465-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207465-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207465-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207465-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207465-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207465-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207465-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207465-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207465-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207465-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207465-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207465-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207465-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207465-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207465-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207465-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207465-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207465-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207465-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207465-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207465-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207465-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207465-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207465-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207465-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207465-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac0d979-ed64-4395-be9a-fc0b6f8c0a4fProduct name120260122
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
07ea0487-5434-6896-2497-013a7ee4afbdProduct name920250311
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2868METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]4Legacy NDC20240308_3516165d-adb2-4dbe-b672-13f7b989d5ed.zip

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METOPROLOL SUCCINATEMETOPROLOL SUCCINATECoupler LLC55f20cc3-d958-bd74-e063-6394a90a78502026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207465
application number: ANDA207465
METOPROLOL SUCCINATEMETOPROLOL SUCCINATEPreferred Pharmaceuticals Inc.7dfe56fe-68b6-4897-9238-0f530c92e27e2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207465
application number: ANDA207465
METOPROLOL SUCCINATEMETOPROLOL SUCCINATENuCare Pharmaceuticals,Inc.a849d489-8f8c-18e6-e053-2995a90a37702024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207465
application number: ANDA207465
METOPROLOL SUCCINATEMETOPROLOL SUCCINATEA-S Medication Solutions91e401fe-ec92-494e-9966-35c280f23efa2023-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207465
application number: ANDA207465
METOPROLOL SUCCINATEMETOPROLOL SUCCINATEA-S Medication Solutions820a962a-5b15-4beb-bd78-e1ac10cb2e0e2023-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207465
application number: ANDA207465
METOPROLOL SUCCINATEMETOPROLOL SUCCINATEBluePoint Laboratories6a4f2446-a9e4-479a-87bd-2d5539dcded92023-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207465
application number: ANDA207465
METOPROLOL SUCCINATEMETOPROLOL SUCCINATEBryant Ranch Prepack5bf27a6c-ea3f-425e-9cfc-a5a308e2af1c2023-07-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207465
application number: ANDA207465
METOPROLOL SUCCINATEMETOPROLOL SUCCINATECipla USA Inc.3a4966a2-2728-4c99-999f-576b3e2df90c2023-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207465
application number: ANDA207465

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2868-07051828680030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2868-0) 2020-09-060000-00-00NoNoCurrent