FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
71335-9753
11-digit product format
713359753
Labeler code
71335
Product ID
71335-9753_adedbdfe-5178-482c-bc6d-da9012328894
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate ER Tablets
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-9753-1Metoprolol Succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE30103
71335-9753-2Metoprolol Succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100103
71335-9753-3Metoprolol Succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE90103
71335-9753-4Metoprolol Succinate120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE120103
71335-9753-5Metoprolol Succinate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE60103
71335-9753-6Metoprolol Succinate180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE180103
71335-9753-7Metoprolol Succinate10 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9753-3EA - Each71335-975383e70375-e9c2-4b56-b2ab-2d599b71e7e512025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9753METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, 7 package rows20240829_a644027d-6f66-4467-a9ac-2ebcf2839744.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNa644027d-6f66-4467-a9ac-2ebcf2839744103
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDa644027d-6f66-4467-a9ac-2ebcf2839744103
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYa644027d-6f66-4467-a9ac-2ebcf2839744103
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYa644027d-6f66-4467-a9ac-2ebcf2839744103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9753-17133597530130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-9753-1) 2023-11-27NoNoHistorical
71335-9753-271335975302100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-9753-2) 2024-01-23NoNoHistorical
71335-9753-37133597530390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-9753-3) 2023-08-16NoNoHistorical
71335-9753-471335975304120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-9753-4) 2024-04-05NoNoHistorical
71335-9753-57133597530560 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-9753-5) 2024-04-05NoNoHistorical
71335-9753-671335975306180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-9753-6) 2024-04-05NoNoHistorical
71335-9753-77133597530710 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-9753-7) 2024-04-05NoNoHistorical