FDA.reportPublic FDA data

Metoprolol Succinate

Product NDC
51655-203
11-digit product format
516550203
Labeler code
51655
Product ID
51655-203_48d28f1e-85e7-e178-e063-6394a90af983
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA204106
Marketing category
ANDA
Marketing start
2020-09-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-203-522023-11-14C16284748780-1f386c649-b960-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS. METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS for Oral Use Initial U.S. Approval: 1992
51655-203-522023-01-30C16284748780-1f386c649-b960-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS. METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS for Oral Use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-203-52Metoprolol Succinate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-203METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20231115_c213c327-68b7-da5b-e053-2a95a90a4028.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNc213c327-68b7-da5b-e053-2a95a90a40283
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDc213c327-68b7-da5b-e053-2a95a90a40283
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYc213c327-68b7-da5b-e053-2a95a90a40283
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYc213c327-68b7-da5b-e053-2a95a90a40283

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-203-525165502035230 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-203-52) 2020-09-010000-00-00NoNoCurrent