LEVOPHED(R) NOREPINEPHRINE BITARTRATE

Product NDC
51662-1315
11-digit product format
516621315
Labeler code
51662
Product ID
51662-1315_ba9ee8b4-ee9c-3d1b-e053-2995a90a11de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOPHED(R) NOREPINEPHRINE BITARTRATE
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA007513
Marketing category
NDA
Marketing start
2018-10-18
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(R) NOREPINEPHRINE BITARTRATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NOREPINEPHRINE BITARTRATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIFY5PE3ZRW
Rxcui242969

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1315-1LEVOPHED(R) NOREPINEPHRINE BITARTRATE4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE46
51662-1315-2LEVOPHED(R) NOREPINEPHRINE BITARTRATE1 mL in 1 POUCHINJECTION, SOLUTION, CONCENTRATE16
51662-1315-3LEVOPHED(R) NOREPINEPHRINE BITARTRATE10 in 1 CASEINJECTION, SOLUTION, CONCENTRATE106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1315LEVOPHED(R) NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [HF ACQUISITION CO LLC, DBA HEALTHFIRST]6Current NDC, Legacy NDC, 3 package rows20210207_788b6c64-1b6d-0058-e053-2a91aa0aa99c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSN788b6c64-1b6d-0058-e053-2a91aa0aa99c6
2429694 ML norepinephrine 1 MG/ML InjectionSCD788b6c64-1b6d-0058-e053-2a91aa0aa99c6
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSY788b6c64-1b6d-0058-e053-2a91aa0aa99c6
242969norepinephrine 4 MG per 4 ML InjectionSY788b6c64-1b6d-0058-e053-2a91aa0aa99c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1315-1516621315014 mL in 1 VIAL, SINGLE-DOSE (51662-1315-1) 4 ml2018-10-180000-00-00NoNoCurrent
51662-1315-2516621315021 mL in 1 POUCH1 mlHistorical
51662-1315-35166213150310 POUCH in 1 CASE (51662-1315-3) / 1 mL in 1 POUCH (51662-1315-2) 10 pouch2020-09-260000-00-00NoNoCurrent