FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
50090-7238
11-digit product format
500907238
Labeler code
50090
Product ID
50090-7238_4b653048-c5f7-485c-9a1b-febe8d60117b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090617
Marketing category
ANDA
Marketing start
2023-04-10
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
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
50090-7238-0Metoprolol succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305
50090-7238-1Metoprolol 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
50090-7238-0EA - Each50090-7238443d73cc-3b62-4c1d-86ae-35055f0e8e4d12024-10-04
50090-7238-1EA - Each50090-7238c5c575fd-03e7-4495-8c28-0852e0f0588a12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7238METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20240913_114346a1-ce49-49d2-9674-2fa6a49749c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN114346a1-ce49-49d2-9674-2fa6a49749c35
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD114346a1-ce49-49d2-9674-2fa6a49749c35
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY114346a1-ce49-49d2-9674-2fa6a49749c35
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY114346a1-ce49-49d2-9674-2fa6a49749c35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7238-05009072380030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-7238-0) 2024-09-10NoNoHistorical
50090-7238-15009072380190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-7238-1) 2024-09-10NoNoHistorical