FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
50090-5720
11-digit product format
500905720
Labeler code
50090
Product ID
50090-5720_b27cac11-6bb2-4e64-922e-899f20ec0dc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate ER Tablets
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211143
Marketing category
ANDA
Marketing start
2020-11-27
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
50090-5720-02023-02-07C16284748780-1f386c649-9bf1-0266-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
50090-5720-12023-02-07C16284748780-1f386c649-9bf1-0266-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
50090-5720-02023-01-30C16284748780-1f386c649-9bf1-0266-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
50090-5720-12023-01-30C16284748780-1f386c649-9bf1-0266-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
50090-5720-0Metoprolol Succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE304
50090-5720-1Metoprolol Succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5720-0EA - Each50090-5720f0fa550d-ca22-4c43-9424-dedf14ff2ad812022-08-04
50090-5720-1EA - Each50090-5720f717e87c-2b90-4929-8a18-d0a46fa3755512022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5720METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 2 package rows20230825_907a35b0-3e0b-40bb-93fd-62b137454b62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN907a35b0-3e0b-40bb-93fd-62b137454b624
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD907a35b0-3e0b-40bb-93fd-62b137454b624
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY907a35b0-3e0b-40bb-93fd-62b137454b624
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY907a35b0-3e0b-40bb-93fd-62b137454b624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5720-05009057200030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5720-0) 2021-09-270000-00-00NoNoCurrent
50090-5720-15009057200190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5720-1) 2021-09-270000-00-00NoNoCurrent