FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
82804-262
11-digit product format
828040262
Labeler code
82804
Product ID
82804-262_f2d7c4da-9df0-44d4-9db3-e47e9cce9254
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA216916
Marketing category
ANDA
Marketing start
2023-10-02
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
82804-262-90Metoprolol Succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-262-90EA - Each82804-2624ab2e7b5-356d-4f35-99dd-61579795952112026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNf2d7c4da-9df0-44d4-9db3-e47e9cce92541
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDf2d7c4da-9df0-44d4-9db3-e47e9cce92541
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYf2d7c4da-9df0-44d4-9db3-e47e9cce92541
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYf2d7c4da-9df0-44d4-9db3-e47e9cce92541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-262-908280402629090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (82804-262-90) 2025-12-15NoNoCurrent