FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
53401-010
11-digit product format
534010010
Labeler code
53401
Product ID
53401-010_522c3807-8557-20a3-e063-6394a90abeb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090617
Marketing category
ANDA
Marketing start
2026-01-13
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol succinate
Listing expiration
2027-12-31

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
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
53401-010-30Metoprolol succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
53401-010-45Metoprolol succinate45 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE451
53401-010-53Metoprolol succinate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601
53401-010-60Metoprolol succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901
53401-010-70Metoprolol succinate120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1201
53401-010-80Metoprolol succinate180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN522c40f2-80f1-e2fc-e063-6294a90ad0911
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD522c40f2-80f1-e2fc-e063-6294a90ad0911
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY522c40f2-80f1-e2fc-e063-6294a90ad0911
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY522c40f2-80f1-e2fc-e063-6294a90ad0911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53401-010-305340100103030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53401-010-30) 2026-05-14NoNoCurrent
53401-010-455340100104545 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53401-010-45) 2026-05-14NoNoCurrent
53401-010-535340100105360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53401-010-53) 2026-05-14NoNoCurrent
53401-010-605340100106090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53401-010-60) 2026-05-14NoNoCurrent
53401-010-7053401001070120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53401-010-70) 2026-05-14NoNoCurrent
53401-010-8053401001080180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53401-010-80) 2026-05-14NoNoCurrent