FDA.reportPublic FDA data

metoprolol succinate

Product NDC
50090-5412
11-digit product format
500905412
Labeler code
50090
Product ID
50090-5412_54291f87-e381-452e-91d8-c4491ece9d50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203894
Marketing category
ANDA
Marketing start
2018-06-07
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
50090-5412-02023-01-30C16284748780-1f386c64a-3a4c-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
50090-5412-0metoprolol succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5412METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20210303_b0e30ebb-cffc-45c0-bc86-355dacffcbf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNb0e30ebb-cffc-45c0-bc86-355dacffcbf81
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDb0e30ebb-cffc-45c0-bc86-355dacffcbf81
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYb0e30ebb-cffc-45c0-bc86-355dacffcbf81
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYb0e30ebb-cffc-45c0-bc86-355dacffcbf81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5412-05009054120090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5412-0) 2020-12-160000-00-00NoNoCurrent