FDA.reportPublic FDA data

METOPROLOL SUCCINATE

Product NDC
61919-334
11-digit product format
619190334
Labeler code
61919
Product ID
61919-334_0e884df8-756d-2374-e063-6394a90ab34a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL SUCCINATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078889
Marketing category
ANDA
Marketing start
2021-01-19
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, 866924

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
61919-334-30METOPROLOL SUCCINATE30 in 1 BOTTLETABLET, EXTENDED RELEASE304
61919-334-90METOPROLOL SUCCINATE90 in 1 BOTTLETABLET, EXTENDED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-334-90EA - Each61919-334acc11d73-2a95-4413-9be5-fdc576597eb512021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-334METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE METOPROLOL TARTRATE TABLET [DIRECT_RX]4Current NDC, Legacy NDC, 2 package rows20240110_90a69a79-5517-0ccf-e053-2995a90a441f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN90a69a79-5517-0ccf-e053-2995a90a441f4
866924metoprolol tartrate 25 MG Oral TabletPSN90a69a79-5517-0ccf-e053-2995a90a441f4
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD90a69a79-5517-0ccf-e053-2995a90a441f4
866924metoprolol tartrate 25 MG Oral TabletSCD90a69a79-5517-0ccf-e053-2995a90a441f4
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY90a69a79-5517-0ccf-e053-2995a90a441f4
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY90a69a79-5517-0ccf-e053-2995a90a441f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-334-306191903343030 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-334-30) 2021-01-190000-00-00NoNoCurrent
61919-334-906191903349090 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-334-90) 2021-01-190000-00-00NoNoCurrent