FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
55154-2642
11-digit product format
551542642
Labeler code
55154
Product ID
55154-2642_b2d7756f-bb25-4f03-bc9f-ad226b719d64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA090617
Marketing category
ANDA
Marketing start
2025-02-24
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
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 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
55154-2642-0Metoprolol succinate1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE12
55154-2642-0Metoprolol succinate10 in 1 BAGTABLET, FILM COATED, EXTENDED RE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2642METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [CARDINAL HEALTH 107, LLC]1Current NDC, 2 package rows20250227_1ab032d6-db68-4108-85d1-56e828d0dc01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN1ab032d6-db68-4108-85d1-56e828d0dc012
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD1ab032d6-db68-4108-85d1-56e828d0dc012
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY1ab032d6-db68-4108-85d1-56e828d0dc012
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY1ab032d6-db68-4108-85d1-56e828d0dc012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-2642-05515426420010 BLISTER PACK in 1 BAG (55154-2642-0) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2025-02-24NoNoCurrent