FDA.reportPublic FDA data

metoprolol succinate

Product NDC
50090-5413
11-digit product format
500905413
Labeler code
50090
Product ID
50090-5413_522ae161-f92d-4ddb-bb0b-74bd64cf6009
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
100 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
50090-5413-02023-01-30C16284748780-1f386c64a-0e74-0266-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
50090-5413-12023-01-30C16284748780-1f386c64a-0e74-0266-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
50090-5413-0metoprolol succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
50090-5413-1metoprolol succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5413-1EA - Each50090-5413d3ac7d63-8c7e-4d96-8d4e-dbe043c1dec412022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5413METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210303_773a3d84-3f82-4f8c-bca1-6e58002753d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN773a3d84-3f82-4f8c-bca1-6e58002753d03
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD773a3d84-3f82-4f8c-bca1-6e58002753d03
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY773a3d84-3f82-4f8c-bca1-6e58002753d03
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY773a3d84-3f82-4f8c-bca1-6e58002753d03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5413-05009054130030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5413-0) 2020-12-160000-00-00NoNoCurrent
50090-5413-15009054130190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5413-1) 2020-12-160000-00-00NoNoCurrent