FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
53401-014
11-digit product format
534010014
Labeler code
53401
Product ID
53401-014_52bdb90d-44c9-b040-e063-6394a90a3ffc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078889
Marketing category
ANDA
Marketing start
2026-01-13
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
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 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
53401-014-30Metoprolol succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
53401-014-53Metoprolol succinate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601
53401-014-60Metoprolol succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901
53401-014-80Metoprolol succinate180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN52bdc5cc-973f-4af6-e063-6294a90aba221
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD52bdc5cc-973f-4af6-e063-6294a90aba221
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY52bdc5cc-973f-4af6-e063-6294a90aba221
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY52bdc5cc-973f-4af6-e063-6294a90aba221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53401-014-305340100143030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53401-014-30) 2026-05-26NoNoCurrent
53401-014-535340100145360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53401-014-53) 2026-05-26NoNoCurrent
53401-014-605340100146090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53401-014-60) 2026-05-26NoNoCurrent
53401-014-8053401001480180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53401-014-80) 2026-05-26NoNoCurrent