FDA.reportPublic FDA data

metoprolol succinate

Product NDC
50090-5418
11-digit product format
500905418
Labeler code
50090
Product ID
50090-5418_ff299226-ff10-4316-9dfe-377c12723b6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203894
Marketing category
ANDA
Marketing start
2018-06-07
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
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
50090-5418-0metoprolol succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE3010
50090-5418-1metoprolol succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE9010
50090-5418-3metoprolol succinate60 in 1 BOTTLETABLET, EXTENDED RELEASE6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5418-0EA - Each50090-5418ceda6687-fc5e-46f3-ade0-a1a10149c0a812022-12-07
50090-5418-1EA - Each50090-54189091d871-d26a-4313-a7cd-ce2ef48484e612022-01-06
50090-5418-3EA - Each50090-54181ae67d81-9469-469b-bf6b-e88413d05db612023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5418METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 3 package rows20250523_cbc32a80-717b-4cf2-b76a-6d03a3720419.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNcbc32a80-717b-4cf2-b76a-6d03a372041910
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDcbc32a80-717b-4cf2-b76a-6d03a372041910
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYcbc32a80-717b-4cf2-b76a-6d03a372041910
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYcbc32a80-717b-4cf2-b76a-6d03a372041910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5418-05009054180030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5418-0) 2020-12-280000-00-00NoNoCurrent
50090-5418-15009054180190 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5418-1) 2020-12-280000-00-00NoNoCurrent
50090-5418-35009054180360 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5418-3) 2020-12-280000-00-00NoNoCurrent