FDA.reportPublic FDA data

METOPROLOL TARTRATE

Product NDC
69367-354
11-digit product format
693670354
Labeler code
69367
Product ID
69367-354_451f6d3f-6a31-fb28-e063-6294a90a06a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA074453
Marketing category
ANDA
Marketing start
2023-12-18
Marketing end
2026-07-31
Substance
METOPROLOL TARTRATE
Active strength
50 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
METOPROLOL TARTRATE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui866511, 866514

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
69367-354-01METOPROLOL TARTRATE100 in 1 BOTTLETABLET1008
69367-354-10METOPROLOL TARTRATE1000 in 1 BOTTLETABLET10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-354METOPROLOL TARTRATE TABLET [WESTMINSTER PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20240815_4d352c34-47f8-4662-9ac5-d5a32bd1660f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSN4d352c34-47f8-4662-9ac5-d5a32bd1660f8
866514metoprolol tartrate 50 MG Oral TabletPSN4d352c34-47f8-4662-9ac5-d5a32bd1660f8
866511metoprolol tartrate 100 MG Oral TabletSCD4d352c34-47f8-4662-9ac5-d5a32bd1660f8
866514metoprolol tartrate 50 MG Oral TabletSCD4d352c34-47f8-4662-9ac5-d5a32bd1660f8
866511metoprolol tartrate 100 MG Oral TabletPSNde781298-37cb-4c03-8431-b6d86ffbde0d1
866514metoprolol tartrate 50 MG Oral TabletPSNde781298-37cb-4c03-8431-b6d86ffbde0d1
866511metoprolol tartrate 100 MG Oral TabletSCDde781298-37cb-4c03-8431-b6d86ffbde0d1
866514metoprolol tartrate 50 MG Oral TabletSCDde781298-37cb-4c03-8431-b6d86ffbde0d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-354-0169367035401100 TABLET in 1 BOTTLE (69367-354-01) 100 tablet2023-12-182026-07-31NoNoHistorical
69367-354-10693670354101000 TABLET in 1 BOTTLE (69367-354-10) 1000 tablet2023-12-182026-07-31NoNoHistorical