FDA.reportPublic FDA data

METOPROLOL SUCCINATE

Product NDC
0527-2602
11-digit product format
005272602
Labeler code
0527
Product ID
0527-2602_1854fb73-0c58-4edd-8b19-8e7d07b1b0d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
NDA019962
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-01-01
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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
0527-2602-372022-01-28C16284748780-19d75b9d0-4375-f424-e053-dadaa90a57cee59f7bb8-5ed7-4c8a-969e-c9905cefcdbb
0527-2602-432022-01-28C16284748780-19d75b9d0-4375-f424-e053-dadaa90a57cee59f7bb8-5ed7-4c8a-969e-c9905cefcdbb
0527-2602-372020-04-28C16284748780-19d75b9d0-4375-f424-e053-dadaa90a57cee59f7bb8-5ed7-4c8a-969e-c9905cefcdbb
0527-2602-432020-04-28C16284748780-19d75b9d0-4375-f424-e053-dadaa90a57cee59f7bb8-5ed7-4c8a-969e-c9905cefcdbb
0527-2602-372020-01-31C16284748780-19d75b9d0-4375-f424-e053-dadaa90a57cee59f7bb8-5ed7-4c8a-969e-c9905cefcdbb
0527-2602-432020-01-31C16284748780-19d75b9d0-4375-f424-e053-dadaa90a57cee59f7bb8-5ed7-4c8a-969e-c9905cefcdbb

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-2602-37EA - Each0527-260201651291-c857-4abe-83f3-8cca0d9efb1112018-01-12
0527-2602-43EA - Each0527-260227e7f780-fbf7-4128-bce5-da22d066b8df12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-2602METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LANNETT COMPANY, INC.]2Legacy NDC20200429_e59f7bb8-5ed7-4c8a-969e-c9905cefcdbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSN1b926135-a67f-4386-a2ba-de5d9fd5a7c52
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSN1b926135-a67f-4386-a2ba-de5d9fd5a7c52
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCD1b926135-a67f-4386-a2ba-de5d9fd5a7c52
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCD1b926135-a67f-4386-a2ba-de5d9fd5a7c52
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSY1b926135-a67f-4386-a2ba-de5d9fd5a7c52
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSY1b926135-a67f-4386-a2ba-de5d9fd5a7c52
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSY1b926135-a67f-4386-a2ba-de5d9fd5a7c52
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSY1b926135-a67f-4386-a2ba-de5d9fd5a7c52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-2602-3700527260237100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2602-37) 2018-01-010000-00-00NoNoCurrent
0527-2602-43005272602431000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-2602-43) 2018-01-010000-00-00NoNoCurrent