FDA.reportPublic FDA data

metoprolol succinate

Product NDC
53002-2781
11-digit product format
530022781
Labeler code
53002
Product ID
53002-2781_1e05b683-991a-464e-86fc-768855bdcce3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
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
2023-12-31
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
53002-2781-02025-01-30C16284748780-12cef2736-7bbf-d83d-e063-dadaa90ab31fThese 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
53002-2781-32025-01-30C16284748780-12cef2736-7bbf-d83d-e063-dadaa90ab31fThese 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
53002-2781-0metoprolol succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002
53002-2781-3metoprolol succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2781METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.]2Legacy NDC, 2 package rows20220421_5784eca7-6090-4672-8fa7-60294eb8b81f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN5784eca7-6090-4672-8fa7-60294eb8b81f2
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD5784eca7-6090-4672-8fa7-60294eb8b81f2
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY5784eca7-6090-4672-8fa7-60294eb8b81f2
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY5784eca7-6090-4672-8fa7-60294eb8b81f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2781-053002278100100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53002-2781-0) 2021-12-310000-00-00NoNoCurrent
53002-2781-35300227810330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53002-2781-3) 2021-12-310000-00-00NoNoCurrent