Metoprolol Tartrate

Product NDC
13107-063
11-digit product format
131070063
Labeler code
13107
Product ID
13107-063_88f1abdc-f53e-4ff9-b4c1-3cfbc2609b79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurolife Pharma LLC
Application
ANDA077739
Marketing category
ANDA
Marketing start
2010-09-17
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
E
Listing certified through
2018-12-31
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
13107-063-012020-01-31C16284748780-19d75b9d0-d39c-f424-e053-dadaa90a57ce88f1abdc-f53e-4ff9-b4c1-3cfbc2609b79
13107-063-992020-01-31C16284748780-19d75b9d0-d39c-f424-e053-dadaa90a57ce88f1abdc-f53e-4ff9-b4c1-3cfbc2609b79

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-063-01Metoprolol Tartrate100 in 1 BOTTLETABLET, FILM COATED1001
13107-063-99Metoprolol Tartrate1000 in 1 BOTTLETABLET, FILM COATED10001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMETOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMETOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMETOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1
SODIUM GLYCOLATEINACTIVE INGREDIENTB75E535IMIMETOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-063METOPROLOL TARTRATE (METOPROLOL TARTRATE ) TABLET, FILM COATED [AUROLIFE PHARMA LLC]1Legacy NDC, 2 package rows20110620_88f1abdc-f53e-4ff9-b4c1-3cfbc2609b79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSN88f1abdc-f53e-4ff9-b4c1-3cfbc2609b791
866924metoprolol tartrate 25 MG Oral TabletPSN88f1abdc-f53e-4ff9-b4c1-3cfbc2609b791
866514metoprolol tartrate 50 MG Oral TabletPSN88f1abdc-f53e-4ff9-b4c1-3cfbc2609b791
866511metoprolol tartrate 100 MG Oral TabletSCD88f1abdc-f53e-4ff9-b4c1-3cfbc2609b791
866924metoprolol tartrate 25 MG Oral TabletSCD88f1abdc-f53e-4ff9-b4c1-3cfbc2609b791
866514metoprolol tartrate 50 MG Oral TabletSCD88f1abdc-f53e-4ff9-b4c1-3cfbc2609b791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
13107-063-0113107006301100 in 1 BOTTLEHistorical
13107-063-99131070063991000 in 1 BOTTLEHistorical