FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
55154-4347
11-digit product format
551544347
Labeler code
55154
Product ID
55154-4347_4f5ce964-79e5-487b-8bed-49ff30eeff90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA078889
Marketing category
ANDA
Marketing start
2024-05-29
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
55154-4347-0Metoprolol Succinate1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE12
55154-4347-0Metoprolol Succinate10 in 1 BAGTABLET, FILM COATED, EXTENDED RE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4347METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [CARDINAL HEALTH 107, LLC]1Current NDC, 2 package rows20240601_450fb603-73d7-422b-a4e2-5a05c13ebe3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN450fb603-73d7-422b-a4e2-5a05c13ebe3b2
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD450fb603-73d7-422b-a4e2-5a05c13ebe3b2
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY450fb603-73d7-422b-a4e2-5a05c13ebe3b2
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY450fb603-73d7-422b-a4e2-5a05c13ebe3b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-4347-05515443470010 BLISTER PACK in 1 BAG (55154-4347-0) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2024-05-29NoNoCurrent