FDA.reportPublic FDA data

metoprolol succinate

Product NDC
50090-5394
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

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5394-02023-01-30C16284748780-1f386c64a-3caa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS. METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
50090-5394-12023-01-30C16284748780-1f386c64a-3caa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS. METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992
50090-5394-32023-01-30C16284748780-1f386c64a-3caa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS. METOPROLOL SUCCINATE extended-release tablets, for oral use Initial U.S. Approval: 1992

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

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
50090-5394-05009053940030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5394-0) 2020-12-010000-00-00NoNoCurrent
50090-5394-15009053940190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5394-1) 2020-12-010000-00-00NoNoCurrent
50090-5394-35009053940360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5394-3) 2020-12-010000-00-00NoNoCurrent