FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
0409-2016
11-digit product format
004092016
Labeler code
0409
Product ID
0409-2016_99c56211-4024-48e5-b46d-840a88f4b16d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL TARTRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA078085
Marketing category
ANDA
Marketing start
2022-06-13
Substance
METOPROLOL TARTRATE
Active strength
1 mg/mL
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 Tartrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE1 mg/mL

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
0409-2016-05Metoprolol Tartrate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION56
0409-2016-10Metoprolol Tartrate10 in 1 CARTONINJECTION, SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2016-05ML - Milliliter0409-2016d6f9b487-8739-48ec-9702-fadbe046bef712022-07-06
0409-2016-10ML - Milliliter0409-2016c4b0b92e-e2f1-483a-a154-c71a27c17b3012022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2016METOPROLOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.]5Current NDC, Legacy NDC, 2 package rows20241129_f65e93ec-4db6-44fa-bff1-8ae89aa8243f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866508metoprolol tartrate 5 MG in 5 ML InjectionPSNf65e93ec-4db6-44fa-bff1-8ae89aa8243f6
8665085 ML metoprolol tartrate 1 MG/ML InjectionSCDf65e93ec-4db6-44fa-bff1-8ae89aa8243f6
866508metoprolol tartrate 5 MG per 5 ML InjectionSYf65e93ec-4db6-44fa-bff1-8ae89aa8243f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-2016-05004092016055 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
0409-2016-100040920161010 VIAL, SINGLE-DOSE in 1 CARTON (0409-2016-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-2016-05) 2022-06-130000-00-00NoNoCurrent