FDA.reportPublic FDA data

metoprolol succinate

Product NDC
51655-193
11-digit product format
516550193
Labeler code
51655
Product ID
51655-193_4af45688-c9dc-f579-e063-6394a90ac5f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA204161
Marketing category
ANDA
Marketing start
2022-10-05
Substance
METOPROLOL SUCCINATE
Active strength
100 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 SUCCINATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTH25PD4CCB
Rxcui866412

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
51655-193-262026-01-29C16284748780-149896155-d687-586f-e063-e6dba90add90These 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
51655-193-522026-01-29C16284748780-149896155-d687-586f-e063-e6dba90add90These 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
51655-193-26metoprolol succinate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE904
51655-193-52metoprolol succinate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-193METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240720_f2b4b132-54a5-c875-e053-2a95a90af443.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNf2b4b132-54a5-c875-e053-2a95a90af4434
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDf2b4b132-54a5-c875-e053-2a95a90af4434
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYf2b4b132-54a5-c875-e053-2a95a90af4434
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYf2b4b132-54a5-c875-e053-2a95a90af4434

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-193-265165501932690 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-193-26) 2022-10-05NoNoHistorical
51655-193-525165501935230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-193-52) 2022-10-05NoNoHistorical