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#

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-944-53EA - Each43353-944dc8ad5d5-164c-4d1a-a0b6-b3ed0c43b08d12014-08-01
43353-944-60EA - Each43353-944b2a77b89-4055-4866-8cb4-4edfffe8c83412014-08-01
43353-944-80EA - Each43353-94480a7cd78-79da-4af3-b38e-0d229af6420412014-08-01

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
43353-944METOPROLOL 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