Norepinephrine

Product NDC
81298-9655
11-digit product format
812989655
Labeler code
81298
Product ID
81298-9655_329c5273-4dc5-4738-bf21-660e73d91eb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norepinephrine Bitartrate
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Long Grove Pharmaceuticals, LLC
Application
NDA214628
Marketing category
NDA
Marketing start
2024-02-02
Substance
NOREPINEPHRINE BITARTRATE
Active strength
32 ug/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
Norepinephrine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NOREPINEPHRINE BITARTRATE32 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIFY5PE3ZRW
Rxcui2475337, 2475340, 2619579

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
81298-9655-1Norepinephrine1 in 1 POUCHSOLUTION12
81298-9655-1Norepinephrine250 mL in 1 BAGSOLUTION2502
81298-9655-3Norepinephrine10 in 1 BOXSOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81298-9655-1ML - Milliliter81298-96555890d340-65f9-4e42-b302-e73b11a174e712024-08-12
81298-9655-3ML - Milliliter81298-9655cb0f1a35-8fea-4138-a6ed-38230de2704312024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81298-9655NOREPINEPHRINE (NOREPINEPHRINE BITARTRATE) SOLUTION [LONG GROVE PHARMACEUTICALS, LLC]1Current NDC, 3 package rows20240202_759807dd-61a8-4f6f-8bf5-f6ee773c81bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2619579norepinephrine bitartrate 16 MG in 250 ML InjectionPSN759807dd-61a8-4f6f-8bf5-f6ee773c81bc2
2475337norepinephrine bitartrate 4 MG in 250 ML InjectionPSN759807dd-61a8-4f6f-8bf5-f6ee773c81bc2
2475340norepinephrine bitartrate 8 MG in 250 ML InjectionPSN759807dd-61a8-4f6f-8bf5-f6ee773c81bc2
2475337250 ML norepinephrine 0.016 MG/ML InjectionSCD759807dd-61a8-4f6f-8bf5-f6ee773c81bc2
2475340250 ML norepinephrine 0.032 MG/ML InjectionSCD759807dd-61a8-4f6f-8bf5-f6ee773c81bc2
2619579250 ML norepinephrine 0.064 MG/ML InjectionSCD759807dd-61a8-4f6f-8bf5-f6ee773c81bc2
2619579norepinephrine (as bitartrate) 16 MG per 250 ML InjectionSY759807dd-61a8-4f6f-8bf5-f6ee773c81bc2
2475337norepinephrine (as bitartrate) 4 MG per 250 ML InjectionSY759807dd-61a8-4f6f-8bf5-f6ee773c81bc2
2475340norepinephrine (as bitartrate) 8 MG per 250 ML InjectionSY759807dd-61a8-4f6f-8bf5-f6ee773c81bc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81298-9655-1812989655011 in 1 POUCHHistorical
81298-9655-38129896550310 POUCH in 1 BOX (81298-9655-3) / 1 BAG in 1 POUCH (81298-9655-1) / 250 mL in 1 BAG10 pouch2024-02-02NoNoCurrent