metoprolol succinate

Product NDC
70518-3143
11-digit product format
705183143
Labeler code
70518
Product ID
70518-3143_5267513e-c9e0-59ba-e063-6394a90a8424
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203894
Marketing category
ANDA
Marketing start
2021-07-05
Substance
METOPROLOL SUCCINATE
Active strength
25 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
metoprolol succinate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866427

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
70518-3143-02023-03-17C16284748780-1f386c64a-344d-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
70518-3143-02023-03-17C16284748780-1f386c64a-344d-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
70518-3143-02023-03-17C16284748780-1f386c64a-344d-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
70518-3143-02023-01-30C16284748780-1f386c64a-344d-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
70518-3143-02023-01-30C16284748780-1f386c64a-344d-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
70518-3143-02023-01-30C16284748780-1f386c64a-344d-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
70518-3143-0metoprolol succinate30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE309
70518-3143-1metoprolol succinate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE909
70518-3143-2metoprolol succinate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3143METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20240927_ea67ed64-47df-4728-8e62-c5d7316a71aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNea67ed64-47df-4728-8e62-c5d7316a71aa9
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDea67ed64-47df-4728-8e62-c5d7316a71aa9
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYea67ed64-47df-4728-8e62-c5d7316a71aa9
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYea67ed64-47df-4728-8e62-c5d7316a71aa9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3143-07051831430030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3143-0) 2021-07-050000-00-00NoNoCurrent
70518-3143-17051831430190 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3143-1) 2021-09-24NoNoCurrent
70518-3143-27051831430230 in 1 BOTTLE, PLASTICHistorical