FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
51655-239
11-digit product format
516550239
Labeler code
51655
Product ID
51655-239_48d2cfb7-9e41-e6da-e063-6294a90a9254
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA213854
Marketing category
ANDA
Marketing start
2023-03-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol succinate
Listing expiration
2027-12-31

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
51655-239-26Metoprolol succinate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE903
51655-239-52Metoprolol succinate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-239METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240713_f80b420c-cc9a-a051-e053-6294a90a8ed9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNf80b420c-cc9a-a051-e053-6294a90a8ed93
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDf80b420c-cc9a-a051-e053-6294a90a8ed93
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYf80b420c-cc9a-a051-e053-6294a90a8ed93
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYf80b420c-cc9a-a051-e053-6294a90a8ed93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-239-265165502392690 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-239-26) 2023-04-10NoNoCurrent
51655-239-525165502395230 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-239-52) 2023-03-20NoNoCurrent