FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
51655-919
11-digit product format
516550919
Labeler code
51655
Product ID
51655-919_49742b7b-65bb-49da-e063-6394a90a353a
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
2023-04-20
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
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 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
51655-919-26Metoprolol succinate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE903
51655-919-52Metoprolol succinate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-919METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240814_fa16cb4e-d70a-d07f-e053-6294a90a9512.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNfa16cb4e-d70a-d07f-e053-6294a90a95123
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDfa16cb4e-d70a-d07f-e053-6294a90a95123
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYfa16cb4e-d70a-d07f-e053-6294a90a95123
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYfa16cb4e-d70a-d07f-e053-6294a90a95123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-919-265165509192690 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-919-26) 2023-04-20NoNoCurrent
51655-919-525165509195230 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-919-52) 2023-05-01NoNoCurrent