Metoprolol

Product NDC
65219-665
11-digit product format
652190665
Labeler code
65219
Product ID
65219-665_ccb1a15e-c943-4042-ae46-550bdabfc96b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL TARTRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA091045
Marketing category
ANDA
Marketing start
2024-12-13
Substance
METOPROLOL TARTRATE
Active strength
5 mg/5mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui866508

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
65219-665-01Metoprolol5 mL in 1 VIALINJECTION, SOLUTION51
65219-665-05Metoprolol10 in 1 TRAYINJECTION, SOLUTION101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866508metoprolol tartrate 5 MG in 5 ML InjectionPSNccb1a15e-c943-4042-ae46-550bdabfc96b1
8665085 ML metoprolol tartrate 1 MG/ML InjectionSCDccb1a15e-c943-4042-ae46-550bdabfc96b1
866508metoprolol tartrate 5 MG per 5 ML InjectionSYccb1a15e-c943-4042-ae46-550bdabfc96b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-665-01652190665015 mL in 1 VIAL5 mlHistorical
65219-665-056521906650510 VIAL in 1 TRAY (65219-665-05) / 5 mL in 1 VIAL (65219-665-01) 10 vial2024-12-13NoNoHistorical