FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
71335-0149
11-digit product format
713350149
Labeler code
71335
Product ID
71335-0149_609cf08a-a8d7-4e20-83e6-05823fb89286
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090617
Marketing category
ANDA
Marketing start
2012-09-10
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol succinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866427, 866436

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
71335-0149-12021-01-14C16284748780-19d75b9d1-1e90-f424-e053-dadaa90a57ceThese 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
71335-0149-22021-01-14C16284748780-19d75b9d1-1e90-f424-e053-dadaa90a57ceThese 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
71335-0149-32021-01-14C16284748780-19d75b9d1-1e90-f424-e053-dadaa90a57ceThese 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
71335-0149-42021-01-14C16284748780-19d75b9d1-1e90-f424-e053-dadaa90a57ceThese 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
71335-0149-52021-01-14C16284748780-19d75b9d1-1e90-f424-e053-dadaa90a57ceThese 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
71335-0149-12020-01-31C16284748780-19d75b9d1-1e90-f424-e053-dadaa90a57ceThese 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
71335-0149-22020-01-31C16284748780-19d75b9d1-1e90-f424-e053-dadaa90a57ceThese 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
71335-0149-32020-01-31C16284748780-19d75b9d1-1e90-f424-e053-dadaa90a57ceThese 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
71335-0149-42020-01-31C16284748780-19d75b9d1-1e90-f424-e053-dadaa90a57ceThese 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
71335-0149-52020-01-31C16284748780-19d75b9d1-1e90-f424-e053-dadaa90a57ceThese 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
71335-0149-1Metoprolol succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE306
71335-0149-2Metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1006
71335-0149-3Metoprolol succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE906
71335-0149-4Metoprolol succinate120 in 1 BOTTLETABLET, EXTENDED RELEASE1206
71335-0149-5Metoprolol succinate60 in 1 BOTTLETABLET, EXTENDED RELEASE606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0149-3EA - Each71335-01495f047433-3ee5-410c-8028-b409b74880d412018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0149METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 5 package rows20231206_42bb324d-8b1e-45db-b15e-3845eec83c38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN42bb324d-8b1e-45db-b15e-3845eec83c386
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN42bb324d-8b1e-45db-b15e-3845eec83c386
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD42bb324d-8b1e-45db-b15e-3845eec83c386
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD42bb324d-8b1e-45db-b15e-3845eec83c386
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY42bb324d-8b1e-45db-b15e-3845eec83c386
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY42bb324d-8b1e-45db-b15e-3845eec83c386
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY42bb324d-8b1e-45db-b15e-3845eec83c386
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY42bb324d-8b1e-45db-b15e-3845eec83c386

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0149-17133501490130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0149-1) 2014-01-280000-00-00NoNoCurrent
71335-0149-271335014902100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0149-2) 2014-01-280000-00-00NoNoCurrent
71335-0149-37133501490390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0149-3) 2014-01-280000-00-00NoNoCurrent
71335-0149-471335014904120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0149-4) 2014-01-280000-00-00NoNoCurrent
71335-0149-57133501490560 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0149-5) 2014-01-280000-00-00NoNoCurrent