FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
82804-978
11-digit product format
828040978
Labeler code
82804
Product ID
82804-978_de781298-37cb-4c03-8431-b6d86ffbde0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074453
Marketing category
ANDA
Marketing start
2023-11-02
Substance
METOPROLOL TARTRATE
Active strength
50 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 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
82804-978-00Metoprolol Tartrate100 in 1 BOTTLETABLET1001
82804-978-11Metoprolol Tartrate1000 in 1 BOTTLETABLET10001
82804-978-30Metoprolol Tartrate30 in 1 BOTTLETABLET301
82804-978-55Metoprolol Tartrate500 in 1 BOTTLETABLET5001
82804-978-60Metoprolol Tartrate60 in 1 BOTTLETABLET601
82804-978-90Metoprolol Tartrate90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-978METOPROLOL TARTRATE TABLET [PROFICIENT RX LP]1Current NDC, 6 package rows20250313_de781298-37cb-4c03-8431-b6d86ffbde0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
82804-978-0082804097800100 TABLET in 1 BOTTLE (82804-978-00) 100 tablet2025-03-11NoNoCurrent
82804-978-11828040978111000 TABLET in 1 BOTTLE (82804-978-11) 1000 tablet2025-03-11NoNoCurrent
82804-978-308280409783030 TABLET in 1 BOTTLE (82804-978-30) 30 tablet2025-03-11NoNoCurrent
82804-978-5582804097855500 TABLET in 1 BOTTLE (82804-978-55) 500 tablet2025-03-11NoNoCurrent
82804-978-608280409786060 TABLET in 1 BOTTLE (82804-978-60) 60 tablet2025-03-11NoNoCurrent
82804-978-908280409789090 TABLET in 1 BOTTLE (82804-978-90) 90 tablet2025-03-11NoNoCurrent