FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
71335-0167
11-digit product format
713350167
Labeler code
71335
Product ID
71335-0167_48bd6b90-f68e-4a25-8c68-907c0376c3ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078889
Marketing category
ANDA
Marketing start
2012-09-10
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
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 SUCCINATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866412

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
71335-0167-12021-06-11C16284748780-19d75b9cf-ebb5-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
71335-0167-22021-06-11C16284748780-19d75b9cf-ebb5-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
71335-0167-32021-06-11C16284748780-19d75b9cf-ebb5-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
71335-0167-42021-06-11C16284748780-19d75b9cf-ebb5-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
71335-0167-52021-06-11C16284748780-19d75b9cf-ebb5-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
71335-0167-62021-06-11C16284748780-19d75b9cf-ebb5-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
71335-0167-12020-01-31C16284748780-19d75b9cf-ebb5-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
71335-0167-22020-01-31C16284748780-19d75b9cf-ebb5-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
71335-0167-32020-01-31C16284748780-19d75b9cf-ebb5-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
71335-0167-42020-01-31C16284748780-19d75b9cf-ebb5-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
71335-0167-52020-01-31C16284748780-19d75b9cf-ebb5-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
71335-0167-62020-01-31C16284748780-19d75b9cf-ebb5-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
71335-0167-1Metoprolol succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE306
71335-0167-2Metoprolol succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE906
71335-0167-3Metoprolol succinate120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1206
71335-0167-4Metoprolol succinate20 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE206
71335-0167-5Metoprolol succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1006
71335-0167-6Metoprolol succinate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE606
71335-0167-7Metoprolol succinate10 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0167-1EA - Each71335-0167a7277842-b2ff-4312-8d33-bf34ec8d569d12018-03-08
71335-0167-2EA - Each71335-0167390d2b20-b7a5-4a01-9e13-c927adf6c44c12018-03-08
71335-0167-3EA - Each71335-0167984eccc0-5e48-4a12-baf9-9fdb39af437312018-03-08
71335-0167-4EA - Each71335-01672b1b32a4-ef54-4222-ac76-ba0767e293ac12018-03-08
71335-0167-5EA - Each71335-016705dd1c69-b1e2-477a-953f-35c447a3910012018-03-08
71335-0167-6EA - Each71335-0167c7643fc7-073f-4652-bd3d-d3e22718ba3512018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0167METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 7 package rows20231110_5d553160-7fcb-413a-8775-c128a1844977.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN5d553160-7fcb-413a-8775-c128a18449776
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD5d553160-7fcb-413a-8775-c128a18449776
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY5d553160-7fcb-413a-8775-c128a18449776
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY5d553160-7fcb-413a-8775-c128a18449776

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0167-17133501670130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0167-1) 2018-02-120000-00-00NoNoCurrent
71335-0167-27133501670290 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0167-2) 2018-02-160000-00-00NoNoCurrent
71335-0167-371335016703120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0167-3) 2018-02-140000-00-00NoNoCurrent
71335-0167-47133501670420 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0167-4) 2022-05-020000-00-00NoNoCurrent
71335-0167-571335016705100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0167-5) 2022-05-020000-00-00NoNoCurrent
71335-0167-67133501670660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0167-6) 2022-05-020000-00-00NoNoCurrent
71335-0167-77133501670710 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0167-7) 2022-05-020000-00-00NoNoCurrent