FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
70518-2080
11-digit product format
705182080
Labeler code
70518
Product ID
70518-2080_388fcc07-60b9-bfe5-e063-6394a90ad22f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078889
Marketing category
ANDA
Marketing start
2019-05-14
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2080-0Metoprolol succinate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE908
70518-2080-1Metoprolol succinate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2080METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 2 package rows20250306_35304060-0965-488d-9e6e-bd1217286ea1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN35304060-0965-488d-9e6e-bd1217286ea18
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD35304060-0965-488d-9e6e-bd1217286ea18
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY35304060-0965-488d-9e6e-bd1217286ea18
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY35304060-0965-488d-9e6e-bd1217286ea18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-2080-07051820800090 in 1 BOTTLE, PLASTICHistorical
70518-2080-17051820800190 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2080-1) 2023-01-19NoNoCurrent