NOREPINEPHRINE BITARTRATE

Product NDC
0338-0042
11-digit product format
003380042
Labeler code
0338
Product ID
0338-0042_b40627c0-67bf-4740-9d21-83054aa6afd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norepinephrine bitartrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA214313
Marketing category
NDA
Marketing start
2023-11-21
Substance
NOREPINEPHRINE BITARTRATE
Active strength
8 mg/250mL
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NOREPINEPHRINE BITARTRATE8 mg/250mL

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-0042-20NOREPINEPHRINE BITARTRATE20 in 1 CARTONINJECTION, SOLUTION2013
0338-0042-20NOREPINEPHRINE BITARTRATE250 mL in 1 BAGINJECTION, SOLUTION25013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2619579norepinephrine bitartrate 16 MG in 250 ML InjectionPSN6363e9b4-29df-4553-904d-a563e5adda6e13
2475337norepinephrine bitartrate 4 MG in 250 ML InjectionPSN6363e9b4-29df-4553-904d-a563e5adda6e13
2475340norepinephrine bitartrate 8 MG in 250 ML InjectionPSN6363e9b4-29df-4553-904d-a563e5adda6e13
2475337250 ML norepinephrine 0.016 MG/ML InjectionSCD6363e9b4-29df-4553-904d-a563e5adda6e13
2475340250 ML norepinephrine 0.032 MG/ML InjectionSCD6363e9b4-29df-4553-904d-a563e5adda6e13
2619579250 ML norepinephrine 0.064 MG/ML InjectionSCD6363e9b4-29df-4553-904d-a563e5adda6e13
2619579norepinephrine (as bitartrate) 16 MG per 250 ML InjectionSY6363e9b4-29df-4553-904d-a563e5adda6e13
2475337norepinephrine (as bitartrate) 4 MG per 250 ML InjectionSY6363e9b4-29df-4553-904d-a563e5adda6e13
2475340norepinephrine (as bitartrate) 8 MG per 250 ML InjectionSY6363e9b4-29df-4553-904d-a563e5adda6e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0338-0042-200033800422020 BAG in 1 CARTON (0338-0042-20) / 250 mL in 1 BAG20 bag2026-02-06NoNoCurrent