FDA.reportPublic FDA data

LEVOPHED

Product NDC
0409-0161
11-digit product format
004090161
Labeler code
0409
Product ID
0409-0161_0fe551f3-b031-4c1b-b567-cc2fc6a52105
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NOREPINEPHRINE BITARTRATE
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA007513
Marketing category
NDA
Marketing start
2024-03-11
Substance
NOREPINEPHRINE BITARTRATE
Active strength
1 mg/mL
Pharmacologic classes
Catecholamine [EPC], Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NOREPINEPHRINE BITARTRATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIFY5PE3ZRW
Rxcui209217, 242969

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ab36713-99a4-1d04-c42f-907afc73b6f9Product name720260105
209a4db0-2639-413d-9ad3-274ad7be11f7Product name120230912
08ddeef6-6d79-428b-a00b-432b50fc2b32Product name120230831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-0161-01LEVOPHED4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE45
0409-0161-10LEVOPHED10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-0161-01ML - Milliliter0409-0161c1fccfe9-96d1-41da-9442-aa7a273312bc12024-04-05
0409-0161-10ML - Milliliter0409-016119a1d79a-897e-4d18-b3bc-d1591eca92e812024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-0161LEVOPHED (NOREPINEPHRINE BITARTRATE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]4Current NDC, 2 package rows20240805_2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209217Levophed 4 MG in 4 ML InjectionPSN2c7dd2b0-cc10-4db6-bf56-6eb154ebeb105
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSN2c7dd2b0-cc10-4db6-bf56-6eb154ebeb105
2092174 ML norepinephrine 1 MG/ML Injection [Levophed]SBD2c7dd2b0-cc10-4db6-bf56-6eb154ebeb105
2429694 ML norepinephrine 1 MG/ML InjectionSCD2c7dd2b0-cc10-4db6-bf56-6eb154ebeb105
2092174 ML Levophed 1 MG/ML InjectionSY2c7dd2b0-cc10-4db6-bf56-6eb154ebeb105
209217Levophed 4 MG per 4 ML InjectionSY2c7dd2b0-cc10-4db6-bf56-6eb154ebeb105
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSY2c7dd2b0-cc10-4db6-bf56-6eb154ebeb105
242969norepinephrine 4 MG per 4 ML InjectionSY2c7dd2b0-cc10-4db6-bf56-6eb154ebeb105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0409-0161-01004090161014 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical
0409-0161-100040901611010 VIAL, SINGLE-DOSE in 1 CARTON (0409-0161-10) / 4 mL in 1 VIAL, SINGLE-DOSE (0409-0161-01) 2024-03-11NoNoCurrent