FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
45865-814
11-digit product format
458650814
Labeler code
45865
Product ID
45865-814_7dc9ad75-896e-b4ba-e053-2991aa0a956f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA090617
Marketing category
ANDA
Marketing start
2012-09-10
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
2019-12-31
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
45865-814-492020-01-31C16284748780-19d75b9d0-1cc9-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use metoprolol succinate safely and effectively. See full prescribing information for metoprolol succinate extended-release tablets . Metoprolol Succinate Extended-Release Tablets USP for Oral Use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-814-49Metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-814METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 1 package rows20181225_7dc9ad75-896d-b4ba-e053-2991aa0a956f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN7dc9ad75-896d-b4ba-e053-2991aa0a956f2
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD7dc9ad75-896d-b4ba-e053-2991aa0a956f2
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY7dc9ad75-896d-b4ba-e053-2991aa0a956f2
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY7dc9ad75-896d-b4ba-e053-2991aa0a956f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-814-4945865081449100 in 1 BOTTLEHistorical