Metoprolol succinate

Product NDC
51655-239
11-digit product format
516550239
Labeler code
51655
Product ID
51655-239_48d2cfb7-9e41-e6da-e063-6294a90a9254
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA213854
Marketing category
ANDA
Marketing start
2023-03-20
Substance
METOPROLOL SUCCINATE
Active strength
25 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213854-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-12
A213854-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-12
A213854-003METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-11-08
A213854-004METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2022-08-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A213854-001AB
A213854-002AB
A213854-003AB
A213854-004AB

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 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213854-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213854-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213854-003METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213854-004METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2022-08-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213854-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213854-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213854-003METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213854-004METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2022-08-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213854-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213854-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213854-003METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213854-004METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2022-08-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213854-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213854-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213854-003METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213854-004METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2022-08-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213854-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213854-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213854-003METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-11-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213854-004METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2022-08-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213854-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213854-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213854-003METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-11-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213854-004METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2022-08-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213854-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213854-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213854-003METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-11-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213854-004METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2022-08-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213854-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213854-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213854-003METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-11-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213854-004METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2022-08-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213854-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213854-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213854-003METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-11-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213854-004METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2022-08-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213854-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A213854-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-02-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A213854-003METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2021-11-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A213854-004METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2022-08-01d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213854-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213854-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213854-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213854-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213854-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213854-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213854-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213854-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213854-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213854-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213854-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213854-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213854-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213854-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213854-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213854-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213854-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213854-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213854-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213854-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213854-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213854-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213854-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213854-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213854-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213854-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213854-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213854-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213854-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213854-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213854-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213854-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213854-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213854-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213854-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213854-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213854-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213854-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213854-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213854-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol succinate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TH25PD4CCBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866427Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f80b420c-cc9a-a051-e053-6294a90a8ed9Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-239-26Metoprolol succinate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE903
51655-239-52Metoprolol succinate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-239METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240713_f80b420c-cc9a-a051-e053-6294a90a8ed9.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol succinateMETOPROLOL SUCCINATEST. MARY'S MEDICAL PARK PHARMACY4136f1e3-b8f4-cb6c-e063-6294a90a03c22026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213854
application number: ANDA213854
Metoprolol succinateMETOPROLOL SUCCINATEST. MARY'S MEDICAL PARK PHARMACY4f59e872-8dab-8c35-e063-6294a90a15d52026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213854
application number: ANDA213854
Metoprolol SuccinateMETOPROLOL SUCCINATEBluePoint Laboratoriesd92dc643-37b1-4d1e-8fc0-cfb27c3e27022026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213854
application number: ANDA213854
Metoprolol succinateMETOPROLOL SUCCINATECoupler LLC48ec9246-f887-2ed4-e063-6394a90ac9522026-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213854
application number: ANDA213854
Metoprolol succinateMETOPROLOL SUCCINATEREMEDYREPACK INC.874a38ba-667e-47b6-a918-a972c0e3ed592026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213854
application number: ANDA213854
Metoprolol succinateMETOPROLOL SUCCINATENorthwind Health Company, LLCf80b420c-cc9a-a051-e053-6294a90a8ed92026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213854
application number: ANDA213854
ndc (product): 51655-239
Metoprolol succinateMETOPROLOL SUCCINATENorthwind Health Company, LLCfa160cd3-4349-8e94-e053-6394a90a58872026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213854
application number: ANDA213854
Metoprolol succinateMETOPROLOL SUCCINATENorthwind Health Company, LLCfa16cb4e-d70a-d07f-e053-6294a90a95122026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213854
application number: ANDA213854
Metoprolol succinateMETOPROLOL SUCCINATEEpic Pharma, LLC2c70177a-615b-4ed7-a58f-a298212e8fae2025-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213854
application number: ANDA213854
Metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepack6103540c-93b5-46e8-9ef3-5059fa0335ab2024-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213854
application number: ANDA213854
Metoprolol succinateMETOPROLOL SUCCINATESlate Run Pharmaceuticals, LLCc00f99e2-7a88-6f9b-e053-2995a90a6ace2024-05-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213854
application number: ANDA213854
Metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutionse780699f-d795-44ce-9828-a0caa6283fb32023-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213854
application number: ANDA213854

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNf80b420c-cc9a-a051-e053-6294a90a8ed93
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDf80b420c-cc9a-a051-e053-6294a90a8ed93
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYf80b420c-cc9a-a051-e053-6294a90a8ed93
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYf80b420c-cc9a-a051-e053-6294a90a8ed93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-239-265165502392690 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-239-26) 2023-04-10NoNoCurrent
51655-239-525165502395230 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-239-52) 2023-03-20NoNoCurrent