Metoprolol succinate

Product NDC
0615-7823
11-digit product format
006157823
Labeler code
0615
Product ID
0615-7823_03a7ffa9-1fe3-4844-8095-4d2945484441
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA090617
Marketing category
ANDA
Marketing start
2012-09-10
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, 866436

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
0615-7823-05Metoprolol succinate15 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1514
0615-7823-28Metoprolol succinate28 in 1 BLISTER PACKTABLET, EXTENDED RELEASE2814
0615-7823-30Metoprolol succinate5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE514
0615-7823-30Metoprolol succinate6 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE614
0615-7823-39Metoprolol succinate30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE3014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL SUCCINATEACTIVE INGREDIENTTH25PD4CCBMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
ETHYLCELLULOSE (10 MPA.S)INACTIVE INGREDIENT3DYK7UYZ62METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
METHYLENE CHLORIDEINACTIVE INGREDIENT588X2YUY0AMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
TALCINACTIVE INGREDIENT7SEV7J4R1UMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-7823METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]14Current NDC, Legacy NDC, 5 package rows20250302_c4fb991c-025c-4a1d-9766-4b62ad70b5fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNc4fb991c-025c-4a1d-9766-4b62ad70b5fe14
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNc4fb991c-025c-4a1d-9766-4b62ad70b5fe14
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDc4fb991c-025c-4a1d-9766-4b62ad70b5fe14
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDc4fb991c-025c-4a1d-9766-4b62ad70b5fe14
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYc4fb991c-025c-4a1d-9766-4b62ad70b5fe14
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYc4fb991c-025c-4a1d-9766-4b62ad70b5fe14
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYc4fb991c-025c-4a1d-9766-4b62ad70b5fe14
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYc4fb991c-025c-4a1d-9766-4b62ad70b5fe14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-7823-050061578230515 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7823-05) 2014-08-210000-00-00NoNoCurrent
0615-7823-280061578232828 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7823-28) 2024-04-17NoNoHistorical
0615-7823-30006157823306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7823-30) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack2015-04-160000-00-00NoNoCurrent
0615-7823-390061578233930 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7823-39) 2014-08-210000-00-00NoNoCurrent