FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
50090-5723
11-digit product format
500905723
Labeler code
50090
Product ID
50090-5723_6bcb7236-a6fe-449b-a3bb-8c7dbe77e2b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate ER Tablets
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211143
Marketing category
ANDA
Marketing start
2020-11-27
Substance
METOPROLOL SUCCINATE
Active strength
50 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 SUCCINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866436

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
50090-5723-0Metoprolol Succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5723-0EA - Each50090-57236af6fa18-c9b9-4f33-aeff-85805ef9124112023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5723METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]5Current NDC, 1 package rows20230918_c8c02764-ef49-4ee4-a3b1-9660cf0e582d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNc8c02764-ef49-4ee4-a3b1-9660cf0e582d5
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDc8c02764-ef49-4ee4-a3b1-9660cf0e582d5
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYc8c02764-ef49-4ee4-a3b1-9660cf0e582d5
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYc8c02764-ef49-4ee4-a3b1-9660cf0e582d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-5723-05009057230090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5723-0) 2021-09-27NoNoHistorical