FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
67544-567
11-digit product format
675440567
Labeler code
67544
Product ID
67544-567_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
25 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
67544-567-302020-01-31C16284748780-19d75b9d0-a822-f424-e053-dadaa90a57ce3859effa-7b9b-41cd-9c90-847fa99e9b34
67544-567-312020-01-31C16284748780-19d75b9d0-a822-f424-e053-dadaa90a57ce3859effa-7b9b-41cd-9c90-847fa99e9b34
67544-567-532020-01-31C16284748780-19d75b9d0-a822-f424-e053-dadaa90a57ce3859effa-7b9b-41cd-9c90-847fa99e9b34
67544-567-602020-01-31C16284748780-19d75b9d0-a822-f424-e053-dadaa90a57ce3859effa-7b9b-41cd-9c90-847fa99e9b34
67544-567-702020-01-31C16284748780-19d75b9d0-a822-f424-e053-dadaa90a57ce3859effa-7b9b-41cd-9c90-847fa99e9b34
67544-567-802020-01-31C16284748780-19d75b9d0-a822-f424-e053-dadaa90a57ce3859effa-7b9b-41cd-9c90-847fa99e9b34
67544-567-922020-01-31C16284748780-19d75b9d0-a822-f424-e053-dadaa90a57ce3859effa-7b9b-41cd-9c90-847fa99e9b34
67544-567-982020-01-31C16284748780-19d75b9d0-a822-f424-e053-dadaa90a57ce3859effa-7b9b-41cd-9c90-847fa99e9b34

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-567-30Metoprolol Tartrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
67544-567-31Metoprolol Tartrate31 in 1 BOTTLE, PLASTICTABLET, FILM COATED312
67544-567-53Metoprolol Tartrate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
67544-567-60Metoprolol Tartrate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902
67544-567-70Metoprolol Tartrate120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1202
67544-567-80Metoprolol Tartrate180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1802
67544-567-92Metoprolol Tartrate270 in 1 BOTTLE, PLASTICTABLET, FILM COATED2702
67544-567-98Metoprolol Tartrate540 in 1 BOTTLE, PLASTICTABLET, FILM COATED5402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-567-30EA - Each67544-567224406be-5395-4844-9a50-3d7d9e3bde7412014-05-02
67544-567-53EA - Each67544-56726193278-461c-48dc-bed1-1ea52d20f27512014-05-02
67544-567-60EA - Each67544-5679562393b-3e17-4882-8875-33d387dfcc2212014-05-02
67544-567-70EA - Each67544-5673bf62da7-2b3e-466c-ae91-cb75f9a7022812014-05-02
67544-567-80EA - Each67544-5674f6d6fd5-a193-4921-a230-f15c940a5fe312014-05-02
67544-567-92EA - Each67544-5675e5af28e-fe62-4632-9d78-7524f2aab45712014-05-02
67544-567-98EA - Each67544-567e3add0cf-dbe5-4bfd-bfc8-aa64c9d5777012014-05-02

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
67544-567METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 8 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
67544-567-306754405673030 in 1 BOTTLE, PLASTICHistorical
67544-567-316754405673131 in 1 BOTTLE, PLASTICHistorical
67544-567-536754405675360 in 1 BOTTLE, PLASTICHistorical
67544-567-606754405676090 in 1 BOTTLE, PLASTICHistorical
67544-567-7067544056770120 in 1 BOTTLE, PLASTICHistorical
67544-567-8067544056780180 in 1 BOTTLE, PLASTICHistorical
67544-567-9267544056792270 in 1 BOTTLE, PLASTICHistorical
67544-567-9867544056798540 in 1 BOTTLE, PLASTICHistorical