FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
63187-768
11-digit product format
631870768
Labeler code
63187
Product ID
63187-768_f2c9155c-5610-4c36-aa1d-7c2e64629bf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078889
Marketing category
ANDA
Marketing start
2012-09-10
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-768-30Metoprolol succinate30 in 1 BOTTLETABLET, EXTENDED RELEASE303
63187-768-60Metoprolol succinate60 in 1 BOTTLETABLET, EXTENDED RELEASE603
63187-768-90Metoprolol succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-768METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20200218_8e39601f-ada5-4ef7-9b53-083cffec79ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN8e39601f-ada5-4ef7-9b53-083cffec79ec3
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD8e39601f-ada5-4ef7-9b53-083cffec79ec3
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY8e39601f-ada5-4ef7-9b53-083cffec79ec3
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY8e39601f-ada5-4ef7-9b53-083cffec79ec3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-768-306318707683030 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-768-30) 2016-11-010000-00-00NoNoCurrent
63187-768-606318707686060 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-768-60) 2016-11-010000-00-00NoNoCurrent
63187-768-906318707689090 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-768-90) 2016-11-010000-00-00NoNoCurrent