FDA.reportPublic FDA data

metoprolol succinate

Product NDC
50090-5411
11-digit product format
500905411
Labeler code
50090
Product ID
50090-5411_fe5aaa7e-03f3-44d7-b0b1-fcd6c0bb83ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203894
Marketing category
ANDA
Marketing start
2018-06-07
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
50090-5411-02023-02-07C16284748780-1f386c649-d590-0266-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
50090-5411-12023-02-07C16284748780-1f386c649-d590-0266-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
50090-5411-02023-01-30C16284748780-1f386c649-d590-0266-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
50090-5411-12023-01-30C16284748780-1f386c649-d590-0266-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
50090-5411-0metoprolol succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE306
50090-5411-1metoprolol succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5411-0EA - Each50090-54111ee72f73-eb54-43d3-b174-ef9bb6e4e84212025-01-14
50090-5411-1EA - Each50090-5411a92abafc-6767-40d5-b1c4-64c394998cfb12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5411METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20241205_712e8b44-c659-4344-8550-ce43f9422300.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN712e8b44-c659-4344-8550-ce43f94223006
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD712e8b44-c659-4344-8550-ce43f94223006
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY712e8b44-c659-4344-8550-ce43f94223006
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY712e8b44-c659-4344-8550-ce43f94223006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5411-05009054110030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5411-0) 2020-12-160000-00-00NoNoCurrent
50090-5411-15009054110190 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5411-1) 2020-12-160000-00-00NoNoCurrent