FDA.reportPublic FDA data

Metoprolol succinate

Product NDC
68071-3828
11-digit product format
680713828
Labeler code
68071
Product ID
68071-3828_32340827-2dbb-dfe5-e063-6294a90ab085
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceutcals, Inc.
Application
ANDA090617
Marketing category
ANDA
Marketing start
2023-04-10
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
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 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
68071-3828-1Metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3828METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTCALS, INC.]1Current NDC, 1 package rows20250409_32341a31-a2db-cf13-e063-6394a90aad89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSN32341a31-a2db-cf13-e063-6394a90aad891
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCD32341a31-a2db-cf13-e063-6394a90aad891
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSY32341a31-a2db-cf13-e063-6394a90aad891
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSY32341a31-a2db-cf13-e063-6394a90aad891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3828-168071382801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3828-1) 2025-04-07NoNoCurrent