FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
43353-943
11-digit product format
433530943
Labeler code
43353
Product ID
43353-943_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
50 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
43353-943-302023-01-30C16284748780-1f386c64a-2d7d-0266-e053-dadaa90a7c1aMetoprolol Tartrate Tablets, USP
43353-943-452023-01-30C16284748780-1f386c64a-2d7d-0266-e053-dadaa90a7c1aMetoprolol Tartrate Tablets, USP
43353-943-532023-01-30C16284748780-1f386c64a-2d7d-0266-e053-dadaa90a7c1aMetoprolol Tartrate Tablets, USP
43353-943-602023-01-30C16284748780-1f386c64a-2d7d-0266-e053-dadaa90a7c1aMetoprolol Tartrate Tablets, USP
43353-943-702023-01-30C16284748780-1f386c64a-2d7d-0266-e053-dadaa90a7c1aMetoprolol Tartrate Tablets, USP
43353-943-732023-01-30C16284748780-1f386c64a-2d7d-0266-e053-dadaa90a7c1aMetoprolol Tartrate Tablets, USP
43353-943-802023-01-30C16284748780-1f386c64a-2d7d-0266-e053-dadaa90a7c1aMetoprolol Tartrate Tablets, USP
43353-943-922023-01-30C16284748780-1f386c64a-2d7d-0266-e053-dadaa90a7c1aMetoprolol Tartrate Tablets, USP
43353-943-942023-01-30C16284748780-1f386c64a-2d7d-0266-e053-dadaa90a7c1aMetoprolol Tartrate Tablets, USP
43353-943-982023-01-30C16284748780-1f386c64a-2d7d-0266-e053-dadaa90a7c1aMetoprolol Tartrate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-943-30Metoprolol Tartrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
43353-943-45Metoprolol Tartrate45 in 1 BOTTLE, PLASTICTABLET, FILM COATED452
43353-943-53Metoprolol Tartrate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
43353-943-60Metoprolol Tartrate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902
43353-943-70Metoprolol Tartrate120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1202
43353-943-73Metoprolol Tartrate135 in 1 BOTTLE, PLASTICTABLET, FILM COATED1352
43353-943-80Metoprolol Tartrate180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1802
43353-943-92Metoprolol Tartrate270 in 1 BOTTLE, PLASTICTABLET, FILM COATED2702
43353-943-94Metoprolol Tartrate360 in 1 BOTTLE, PLASTICTABLET, FILM COATED3602
43353-943-98Metoprolol Tartrate540 in 1 BOTTLE, PLASTICTABLET, FILM COATED5402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-943-30EA - Each43353-9433eb39699-8431-4047-a100-2aaf06c471a112014-08-01
43353-943-45EA - Each43353-943803e0da6-8b7a-4cd5-b01a-f6d4e7f7eb2012014-08-01
43353-943-53EA - Each43353-9432e2903cd-37c2-4770-852b-be9e88f2873d12014-08-01
43353-943-60EA - Each43353-943a3fc7d93-59ff-4ea2-a431-c5b1715a2a5312014-08-01
43353-943-70EA - Each43353-943c3bb952f-492f-465a-b675-890cb1371ce612014-08-01
43353-943-73EA - Each43353-943bd13a160-37fa-4444-a573-d36c1b06efe312014-08-01
43353-943-80EA - Each43353-94379873b58-ffc2-4937-a466-c1091153706412014-08-01
43353-943-92EA - Each43353-943166328d9-007e-4ec3-9b5d-c1407ea09d0812014-08-01
43353-943-94EA - Each43353-9438c96ad4b-f25c-4135-95b8-72e7bcb0f73f12014-08-01
43353-943-98EA - Each43353-943bf981c64-1e34-4445-93cc-ce1060f4c1f112014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-943METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 10 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
43353-943-304335309433030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-943-30) 2014-06-090000-00-00NoNoCurrent
43353-943-454335309434545 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-943-45) 2014-06-090000-00-00NoNoCurrent
43353-943-534335309435360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-943-53) 2014-06-090000-00-00NoNoCurrent
43353-943-604335309436090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-943-60) 2014-05-200000-00-00NoNoCurrent
43353-943-7043353094370120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-943-70) 2015-04-130000-00-00NoNoCurrent
43353-943-7343353094373135 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-943-73) 2014-10-110000-00-00NoNoCurrent
43353-943-8043353094380180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-943-80) 2014-05-200000-00-00NoNoCurrent
43353-943-9243353094392270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-943-92) 2014-05-240000-00-00NoNoCurrent
43353-943-9443353094394360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-943-94) 2014-08-160000-00-00NoNoCurrent
43353-943-9843353094398540 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-943-98) 2014-08-160000-00-00NoNoCurrent