FDA.reportPublic FDA data

metoprolol succinate

Product NDC
68071-2522
11-digit product format
680712522
Labeler code
68071
Product ID
68071-2522_1e79cefa-a416-38b6-e063-6394a90a5eb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203894
Marketing category
ANDA
Marketing start
2018-06-07
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2522-12024-07-30C16284748780-1f386c649-cd7c-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
68071-2522-12023-01-30C16284748780-1f386c649-cd7c-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
68071-2522-1metoprolol succinate100 in 1 BOTTLETABLET, EXTENDED RELEASE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2522METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 1 package rows20240731_ca8dbdc1-0137-8a89-e053-2995a90a66fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNca8dbdc1-0137-8a89-e053-2995a90a66fd2
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDca8dbdc1-0137-8a89-e053-2995a90a66fd2
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYca8dbdc1-0137-8a89-e053-2995a90a66fd2
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYca8dbdc1-0137-8a89-e053-2995a90a66fd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2522-168071252201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-2522-1) 2021-08-270000-00-00NoNoCurrent