FDA.reportPublic FDA data

METOPROLOL SUCCINATE

Product NDC
50816-200
11-digit product format
508160200
Labeler code
50816
Product ID
50816-200_e4cd6ed2-e776-32d1-e053-2a95a90aa8ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
New American Therapeutics
Application
NDA019962
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-01-01
Marketing end
0000-00-00
Substance
METOPROLOL SUCCINATE
Active strength
200 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
50816-200-022025-01-30C16284748780-1d6a99b39-b691-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Metoprolol Succinate safely and effectively. See full prescribing information for Metoprolol Succinate. Metoprolol Succinate Tablet, Extended-Release for Oral Use Initial U.S. Approval: 2006
50816-200-032025-01-30C16284748780-1d6a99b39-b691-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Metoprolol Succinate safely and effectively. See full prescribing information for Metoprolol Succinate. Metoprolol Succinate Tablet, Extended-Release for Oral Use Initial U.S. Approval: 2006
50816-200-022022-05-17C16284748780-1d6a99b39-b691-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Metoprolol Succinate safely and effectively. See full prescribing information for Metoprolol Succinate. Metoprolol Succinate Tablet, Extended-Release for Oral Use Initial U.S. Approval: 2006
50816-200-032022-05-17C16284748780-1d6a99b39-b691-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Metoprolol Succinate safely and effectively. See full prescribing information for Metoprolol Succinate. Metoprolol Succinate Tablet, Extended-Release for Oral Use Initial U.S. Approval: 2006
50816-200-022022-01-28C16284748780-1d6a99b39-b691-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Metoprolol Succinate safely and effectively. See full prescribing information for Metoprolol Succinate. Metoprolol Succinate Tablet, Extended-Release for Oral Use Initial U.S. Approval: 2006
50816-200-032022-01-28C16284748780-1d6a99b39-b691-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Metoprolol Succinate safely and effectively. See full prescribing information for Metoprolol Succinate. Metoprolol Succinate Tablet, Extended-Release for Oral Use Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50816-200-02METOPROLOL SUCCINATE100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
50816-200-03METOPROLOL SUCCINATE1000 in 1 BOTTLETABLET, EXTENDED RELEASE10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50816-200METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NEW AMERICAN THERAPEUTICS]9Legacy NDC, 2 package rows20230425_d66c1b47-e67f-4b5c-9290-f90bbb378971.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNd66c1b47-e67f-4b5c-9290-f90bbb3789719
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSNd66c1b47-e67f-4b5c-9290-f90bbb3789719
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNd66c1b47-e67f-4b5c-9290-f90bbb3789719
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNd66c1b47-e67f-4b5c-9290-f90bbb3789719
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDd66c1b47-e67f-4b5c-9290-f90bbb3789719
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCDd66c1b47-e67f-4b5c-9290-f90bbb3789719
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDd66c1b47-e67f-4b5c-9290-f90bbb3789719
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDd66c1b47-e67f-4b5c-9290-f90bbb3789719
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN1e487de1-848a-4ee8-929b-406dac3791661
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD1e487de1-848a-4ee8-929b-406dac3791661
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY1e487de1-848a-4ee8-929b-406dac3791661
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY1e487de1-848a-4ee8-929b-406dac3791661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50816-200-025081602000212 BOTTLE in 1 PACKAGE (50816-200-02) > 100 TABLET, EXTENDED RELEASE in 1 BOTTLE12 bottle2020-08-310000-00-00NoNoCurrent
50816-200-03508160200036 BOTTLE in 1 PACKAGE (50816-200-03) > 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE6 bottle2020-08-310000-00-00NoNoCurrent