metoprolol succinate

Product NDC
50090-5394
Requested package NDC
50090-5394-3
11-digit product format
500905394
Labeler code
50090
Product ID
50090-5394_67c60e00-07dc-474e-b396-fb39e1b22f65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204161
Marketing category
ANDA
Marketing start
2019-10-23
Marketing end
0000-00-00
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
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-539450090-5394-3IInactivated by FDA2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A204161-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25
A204161-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25
A204161-003METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25
A204161-004METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204161-001AB
A204161-002AB
A204161-003AB
A204161-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204161-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A204161-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A204161-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A204161-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2016-11-25d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204161-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204161-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204161-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204161-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204161-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204161-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204161-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204161-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204161-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204161-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204161-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204161-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204161-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204161-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204161-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204161-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204161-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204161-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204161-004AB1d06236e962d9…

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5394-0metoprolol succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
50090-5394-1metoprolol succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE903
50090-5394-3metoprolol succinate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5394-1EA - Each50090-53946c2750b5-7875-4543-86e5-7a3c7c890d0712022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5394METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 3 package rows20210303_2a9a2bb6-8816-451a-99f3-a41e0302b4f5.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
metoprolol succinateMETOPROLOL SUCCINATENorthwind Health Company, LLCf2b4b132-54a5-c875-e053-2a95a90af4432026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204161
application number: ANDA204161
metoprolol succinateMETOPROLOL SUCCINATENorthwind Health Company, LLCf3192894-6298-1b54-e053-2995a90ab2e02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204161
application number: ANDA204161
metoprolol succinateMETOPROLOL SUCCINATENorthwind Health Company, LLCf76d782a-59fe-2093-e053-6394a90a86682026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204161
application number: ANDA204161
metoprolol succinateMETOPROLOL SUCCINATEActavis Pharma, Inc.b798601e-a369-4c8b-8235-08900e1b751d2024-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204161
application number: ANDA204161
metoprolol succinateMETOPROLOL SUCCINATEProficient Rx LP57e33bcf-b380-44bb-b96e-3a637af6233a2023-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204161
application number: ANDA204161
metoprolol succinateMETOPROLOL SUCCINATEProficient Rx LP64c65611-d5c9-4802-9edd-32c7c67ce6f42023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204161
application number: ANDA204161

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN2a9a2bb6-8816-451a-99f3-a41e0302b4f53
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD2a9a2bb6-8816-451a-99f3-a41e0302b4f53
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY2a9a2bb6-8816-451a-99f3-a41e0302b4f53
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY2a9a2bb6-8816-451a-99f3-a41e0302b4f53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5394-35009053940360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5394-3) 2020-12-010000-00-00NoNoCurrent