FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
72572-420
11-digit product format
725720420
Labeler code
72572
Product ID
72572-420_08b65561-0817-44e6-a23b-b68ab6ee2666
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoroprolol Tartrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA077761
Marketing category
ANDA
Marketing start
2019-12-10
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 Tartrate
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
72572-420-01Metoprolol Tartrate5 mL in 1 VIALINJECTION, SOLUTION54
72572-420-10Metoprolol Tartrate10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-420-01ML - Milliliter72572-42081709d02-b81b-4285-83d1-7b8adf00a0c312019-12-10
72572-420-10ML - Milliliter72572-4204e3554e1-858f-439c-9ea5-e6aa511c77f712019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-420METOPROLOL TARTRATE (METOROPROLOL TARTRATE) INJECTION, SOLUTION [CIVICA, INC.]3Current NDC, Legacy NDC, 2 package rows20240704_8dae76a2-32e7-40a2-bb70-9c6380b9b330.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866508metoprolol tartrate 5 MG in 5 ML InjectionPSN8dae76a2-32e7-40a2-bb70-9c6380b9b3304
8665085 ML metoprolol tartrate 1 MG/ML InjectionSCD8dae76a2-32e7-40a2-bb70-9c6380b9b3304
866508metoprolol tartrate 5 MG per 5 ML InjectionSY8dae76a2-32e7-40a2-bb70-9c6380b9b3304

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-420-01725720420015 mL in 1 VIAL5 mlHistorical
72572-420-107257204201010 VIAL in 1 CARTON (72572-420-10) / 5 mL in 1 VIAL (72572-420-01) 10 vial2019-12-100000-00-00NoNoCurrent