FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
67544-627
11-digit product format
675440627
Labeler code
67544
Product ID
67544-627_f3bcf3f8-72ce-4359-877e-13cef7ecf1c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076704
Marketing category
ANDA
Marketing start
2013-04-22
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
2019-12-31
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
67544-627-312020-01-31C16284748780-19d75b9d0-a822-f424-e053-dadaa90a57ce3859effa-7b9b-41cd-9c90-847fa99e9b34
67544-627-532020-01-31C16284748780-19d75b9d0-a822-f424-e053-dadaa90a57ce3859effa-7b9b-41cd-9c90-847fa99e9b34
67544-627-602020-01-31C16284748780-19d75b9d0-a822-f424-e053-dadaa90a57ce3859effa-7b9b-41cd-9c90-847fa99e9b34
67544-627-802020-01-31C16284748780-19d75b9d0-a822-f424-e053-dadaa90a57ce3859effa-7b9b-41cd-9c90-847fa99e9b34

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-627-31Metoprolol Tartrate31 in 1 BOTTLE, PLASTICTABLET, FILM COATED312
67544-627-53Metoprolol Tartrate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
67544-627-60Metoprolol Tartrate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902
67544-627-80Metoprolol Tartrate180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-627-53EA - Each67544-627dab11da9-2870-4417-ad74-4c74059ee6fa12014-05-02
67544-627-60EA - Each67544-627d097bee5-fb88-409f-af87-a182d7d32d3e12014-05-02
67544-627-80EA - Each67544-627f0e7a3f3-2686-46ad-a8b1-254693f0dc0f12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-627METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 4 package rows20140415_3859effa-7b9b-41cd-9c90-847fa99e9b34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSN3859effa-7b9b-41cd-9c90-847fa99e9b342
866924metoprolol tartrate 25 MG Oral TabletPSN3859effa-7b9b-41cd-9c90-847fa99e9b342
866514metoprolol tartrate 50 MG Oral TabletPSN3859effa-7b9b-41cd-9c90-847fa99e9b342
866511metoprolol tartrate 100 MG Oral TabletSCD3859effa-7b9b-41cd-9c90-847fa99e9b342
866924metoprolol tartrate 25 MG Oral TabletSCD3859effa-7b9b-41cd-9c90-847fa99e9b342
866514metoprolol tartrate 50 MG Oral TabletSCD3859effa-7b9b-41cd-9c90-847fa99e9b342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-627-316754406273131 in 1 BOTTLE, PLASTICHistorical
67544-627-536754406275360 in 1 BOTTLE, PLASTICHistorical
67544-627-606754406276090 in 1 BOTTLE, PLASTICHistorical
67544-627-8067544062780180 in 1 BOTTLE, PLASTICHistorical