FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
0378-4593
11-digit product format
003784593
Labeler code
0378
Product ID
0378-4593_57d60035-d408-4f98-932e-2cbbeae5326c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076704
Marketing category
ANDA
Marketing start
2016-03-29
Substance
METOPROLOL TARTRATE
Active strength
37.5 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol Tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui866511, 866514, 866924, 1606347, 1606349

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-4593-01Metoprolol Tartrate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4593-01EA - Each0378-45933c89dbd8-23db-4042-8552-f7b388e8161612016-04-04
0378-4593-05EA - Each0378-45935a60c7a2-caef-46ca-a6a0-98b16ba4153012016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
TRIACETININACTIVE INGREDIENTXHX3C3X673METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-4593METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]31Current NDC, Legacy NDC, 1 package rows20240302_809c6386-0039-42ff-a03e-e42733e229b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSN809c6386-0039-42ff-a03e-e42733e229b831
866924metoprolol tartrate 25 MG Oral TabletPSN809c6386-0039-42ff-a03e-e42733e229b831
1606347metoprolol tartrate 37.5 MG Oral TabletPSN809c6386-0039-42ff-a03e-e42733e229b831
866514metoprolol tartrate 50 MG Oral TabletPSN809c6386-0039-42ff-a03e-e42733e229b831
1606349metoprolol tartrate 75 MG Oral TabletPSN809c6386-0039-42ff-a03e-e42733e229b831
866511metoprolol tartrate 100 MG Oral TabletSCD809c6386-0039-42ff-a03e-e42733e229b831
866924metoprolol tartrate 25 MG Oral TabletSCD809c6386-0039-42ff-a03e-e42733e229b831
1606347metoprolol tartrate 37.5 MG Oral TabletSCD809c6386-0039-42ff-a03e-e42733e229b831
866514metoprolol tartrate 50 MG Oral TabletSCD809c6386-0039-42ff-a03e-e42733e229b831
1606349metoprolol tartrate 75 MG Oral TabletSCD809c6386-0039-42ff-a03e-e42733e229b831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-4593-0100378459301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4593-01) 2016-03-290000-00-00NoNoCurrent