FDA.reportPublic FDA data

NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE

Product NDC
44567-640
11-digit product format
445670640
Labeler code
44567
Product ID
44567-640_a0cf3162-9ed3-4774-a076-fc8af5bbe3d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NOREPINEPHRINE BITARTRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
NDA215700
Marketing category
NDA
Marketing start
2022-09-15
Substance
NOREPINEPHRINE BITARTRATE
Active strength
.016 mg/mL
Pharmacologic classes
Catecholamine [EPC], Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NOREPINEPHRINE BITARTRATE.016 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIFY5PE3ZRW
Rxcui2475337, 2475340, 2619579, 2725614

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
44567-640-01NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE250 mL in 1 BAGINJECTION, SOLUTION25010
44567-640-10NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE10 in 1 CARTONINJECTION, SOLUTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-640-01ML - Milliliter44567-6400d2045d8-a469-478c-a1a5-ae79d040afba12023-04-07
44567-640-10ML - Milliliter44567-640b3c0add3-0ab9-41cd-b971-0912584521ce12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-640NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE (NOREPINEPHRINE BITARTRATE) INJECTION, SOLUTION [WG CRITICAL CARE, LLC]7Current NDC, Legacy NDC, 2 package rows20240621_ddbef60d-c20a-4ada-928f-e87074c08a54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2619579norepinephrine bitartrate 16 MG in 250 ML InjectionPSNddbef60d-c20a-4ada-928f-e87074c08a5410
2725614norepinephrine bitartrate 32 MG in 250 ML InjectionPSNddbef60d-c20a-4ada-928f-e87074c08a5410
2475337norepinephrine bitartrate 4 MG in 250 ML InjectionPSNddbef60d-c20a-4ada-928f-e87074c08a5410
2475340norepinephrine bitartrate 8 MG in 250 ML InjectionPSNddbef60d-c20a-4ada-928f-e87074c08a5410
2475337250 ML norepinephrine 0.016 MG/ML InjectionSCDddbef60d-c20a-4ada-928f-e87074c08a5410
2475340250 ML norepinephrine 0.032 MG/ML InjectionSCDddbef60d-c20a-4ada-928f-e87074c08a5410
2619579250 ML norepinephrine 0.064 MG/ML InjectionSCDddbef60d-c20a-4ada-928f-e87074c08a5410
2725614250 ML norepinephrine 0.128 MG/ML InjectionSCDddbef60d-c20a-4ada-928f-e87074c08a5410
2619579norepinephrine (as bitartrate) 16 MG per 250 ML InjectionSYddbef60d-c20a-4ada-928f-e87074c08a5410
2725614norepinephrine (as bitartrate) 32 MG per 250 ML InjectionSYddbef60d-c20a-4ada-928f-e87074c08a5410
2475337norepinephrine (as bitartrate) 4 MG per 250 ML InjectionSYddbef60d-c20a-4ada-928f-e87074c08a5410
2475340norepinephrine (as bitartrate) 8 MG per 250 ML InjectionSYddbef60d-c20a-4ada-928f-e87074c08a5410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-640-0144567064001250 mL in 1 BAG250 mlHistorical
44567-640-104456706401010 BAG in 1 CARTON (44567-640-10) / 250 mL in 1 BAG (44567-640-01) 10 bag2022-10-310000-00-00NoNoCurrent