FDA.reportPublic FDA data

METOPROLOL SUCCINATE

Product NDC
50090-5950
11-digit product format
500905950
Labeler code
50090
Product ID
50090-5950_3659545d-2d49-4fbf-8e37-085dc87c3cbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL SUCCINATE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205541
Marketing category
ANDA
Marketing start
2020-11-06
Marketing end
0000-00-00
Substance
METOPROLOL SUCCINATE
Active strength
50 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
50090-5950-02024-01-30C16284748780-11030e365-01f8-111a-e063-dadaa90a10e2These 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
50090-5950-12024-01-30C16284748780-11030e365-01f8-111a-e063-dadaa90a10e2These 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
50090-5950-0METOPROLOL SUCCINATE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
50090-5950-1METOPROLOL SUCCINATE90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5950-0EA - Each50090-59509fbfa5e6-3014-4be5-a5d1-1986c8c498ff12022-07-06
50090-5950-1EA - Each50090-59506a3b9dd1-0b14-44a8-a2c0-1ae6669c3d6212022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5950METOPROLOL SUCCINATE (METOPROLOL SUCCINATE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20220412_9526ac20-68f5-49d4-8f46-8b26df0771f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN9526ac20-68f5-49d4-8f46-8b26df0771f31
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD9526ac20-68f5-49d4-8f46-8b26df0771f31
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY9526ac20-68f5-49d4-8f46-8b26df0771f31
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY9526ac20-68f5-49d4-8f46-8b26df0771f31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5950-05009059500030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5950-0) 2022-04-040000-00-00NoNoCurrent
50090-5950-15009059500190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5950-1) 2022-04-040000-00-00NoNoCurrent