FDA.reportPublic FDA data

Metoprolol

Product NDC
63323-660
11-digit product format
633230660
Labeler code
63323
Product ID
63323-660_4066607a-15cb-42ac-999e-5254907dda5a
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
2010-10-28
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
63323-660-01Metoprolol5 mL in 1 VIALINJECTION, SOLUTION56
63323-660-05Metoprolol10 in 1 TRAYINJECTION, SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-660-01ML - Milliliter63323-6601f8deab4-2d36-43ca-af59-c0b93dc8d86112025-05-14
63323-660-05ML - Milliliter63323-6603fb54e13-15b4-41e1-8a65-22ab42f1b05012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL (METOPROLOL TARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL (METOPROLOL TARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMETOPROLOL (METOPROLOL TARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-660METOPROLOL (METOPROLOL TARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]5Current NDC, Legacy NDC, 2 package rows20211117_be1c686e-37a5-4a53-945b-68a6ead35134.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866508metoprolol tartrate 5 MG in 5 ML InjectionPSNbe1c686e-37a5-4a53-945b-68a6ead351346
8665085 ML metoprolol tartrate 1 MG/ML InjectionSCDbe1c686e-37a5-4a53-945b-68a6ead351346
866508metoprolol tartrate 5 MG per 5 ML InjectionSYbe1c686e-37a5-4a53-945b-68a6ead351346
866508metoprolol tartrate 5 MG in 5 ML InjectionPSN993c3a0d-5472-3de3-e053-2995a90acdf63
8665085 ML metoprolol tartrate 1 MG/ML InjectionSCD993c3a0d-5472-3de3-e053-2995a90acdf63
866508metoprolol tartrate 5 MG per 5 ML InjectionSY993c3a0d-5472-3de3-e053-2995a90acdf63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-660-01633230660015 mL in 1 VIAL5 mlHistorical
63323-660-056332306600510 VIAL in 1 TRAY (63323-660-05) / 5 mL in 1 VIAL (63323-660-01) 10 vial2010-10-280000-00-00NoNoCurrent