FDA.reportPublic FDA data

Levophed

Product NDC
0409-1443
11-digit product format
004091443
Labeler code
0409
Product ID
0409-1443_97577c7d-6187-4f2e-b7a0-f5f5edfb7803
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
2013-07-01
Marketing end
0000-00-00
Substance
NOREPINEPHRINE BITARTRATE
Active strength
1 mg/mL
Pharmacologic classes
Catecholamine [EPC],Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
0409-1443-04LEVOPHED10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE1020
0409-1443-14LEVOPHED4 mL in 1 AMPULEINJECTION, SOLUTION, CONCENTRATE420

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1443-04ML - Milliliter0409-1443caf7dd8b-32df-4fdd-8ab0-ca4ca4d3e4ae12012-07-24
0409-1443-14ML - Milliliter0409-1443820aaa38-7454-4ff7-bfaa-7c3efddd695b12019-07-02
0409-1443-25ML - Milliliter0409-14433e2b19a4-5130-4e85-8e60-33e310b00fad12014-05-02
0409-1443-55ML - Milliliter0409-1443b3a92a08-47d2-424f-b00b-0315c04691d212020-01-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NOREPINEPHRINE BITARTRATEACTIVE INGREDIENTIFY5PE3ZRWLEVOPHED (NOREPINEPHRINE BITARTRATE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]10
NOREPINEPHRINEACTIVE MOIETYX4W3ENH1CVLEVOPHED (NOREPINEPHRINE BITARTRATE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]10
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLEVOPHED (NOREPINEPHRINE BITARTRATE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]10
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CLEVOPHED (NOREPINEPHRINE BITARTRATE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1443LEVOPHED (NOREPINEPHRINE BITARTRATE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]19Legacy NDC, 2 package rows20240805_c4de72a8-2a75-4984-ce90-e4870226dc12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209217Levophed 4 MG in 4 ML InjectionPSNc4de72a8-2a75-4984-ce90-e4870226dc1220
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSNc4de72a8-2a75-4984-ce90-e4870226dc1220
2092174 ML norepinephrine 1 MG/ML Injection [Levophed]SBDc4de72a8-2a75-4984-ce90-e4870226dc1220
2429694 ML norepinephrine 1 MG/ML InjectionSCDc4de72a8-2a75-4984-ce90-e4870226dc1220
2092174 ML Levophed 1 MG/ML InjectionSYc4de72a8-2a75-4984-ce90-e4870226dc1220
209217Levophed 4 MG per 4 ML InjectionSYc4de72a8-2a75-4984-ce90-e4870226dc1220
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSYc4de72a8-2a75-4984-ce90-e4870226dc1220
242969norepinephrine 4 MG per 4 ML InjectionSYc4de72a8-2a75-4984-ce90-e4870226dc1220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0409-1443-040040914430410 in 1 CARTONHistorical
0409-1443-14004091443144 mL in 1 AMPULE4 mlHistorical