FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
43353-944
11-digit product format
433530944
Labeler code
43353
Product ID
43353-944_0a6b19da-4bd2-491a-973b-ef08f2f13fe2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077739
Marketing category
ANDA
Marketing start
2007-09-11
Marketing end
0000-00-00
Substance
METOPROLOL TARTRATE
Active strength
100 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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
43353-944-532023-01-30C16284748780-1f386c64a-2d7d-0266-e053-dadaa90a7c1aMetoprolol Tartrate Tablets, USP
43353-944-602023-01-30C16284748780-1f386c64a-2d7d-0266-e053-dadaa90a7c1aMetoprolol Tartrate Tablets, USP
43353-944-802023-01-30C16284748780-1f386c64a-2d7d-0266-e053-dadaa90a7c1aMetoprolol Tartrate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-944-53Metoprolol Tartrate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
43353-944-60Metoprolol Tartrate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902
43353-944-80Metoprolol Tartrate180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-944METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 3 package rows20191221_25b46f8a-feff-4375-a6f5-15db7bc43a6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSN25b46f8a-feff-4375-a6f5-15db7bc43a6d2
866924metoprolol tartrate 25 MG Oral TabletPSN25b46f8a-feff-4375-a6f5-15db7bc43a6d2
866514metoprolol tartrate 50 MG Oral TabletPSN25b46f8a-feff-4375-a6f5-15db7bc43a6d2
866511metoprolol tartrate 100 MG Oral TabletSCD25b46f8a-feff-4375-a6f5-15db7bc43a6d2
866924metoprolol tartrate 25 MG Oral TabletSCD25b46f8a-feff-4375-a6f5-15db7bc43a6d2
866514metoprolol tartrate 50 MG Oral TabletSCD25b46f8a-feff-4375-a6f5-15db7bc43a6d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-944-534335309445360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-944-53) 2014-06-090000-00-00NoNoCurrent
43353-944-604335309446090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-944-60) 2014-05-240000-00-00NoNoCurrent
43353-944-8043353094480180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-944-80) 2014-05-190000-00-00NoNoCurrent