norepinephrine bitartrate

Product NDC
72205-241
11-digit product format
722050241
Labeler code
72205
Product ID
72205-241_4b054c27-ed64-40e2-8eba-b7f2ec780a82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norepinephrine bitartrate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA218595
Marketing category
ANDA
Marketing start
2025-12-11
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-241-07norepinephrine bitartrate4 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE41
72205-241-07norepinephrine bitartrate10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSN4b054c27-ed64-40e2-8eba-b7f2ec780a821
2429694 ML norepinephrine 1 MG/ML InjectionSCD4b054c27-ed64-40e2-8eba-b7f2ec780a821
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSY4b054c27-ed64-40e2-8eba-b7f2ec780a821
242969norepinephrine 4 MG per 4 ML InjectionSY4b054c27-ed64-40e2-8eba-b7f2ec780a821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-241-077220502410710 VIAL in 1 CARTON (72205-241-07) / 4 mL in 1 VIAL10 vial2025-12-11NoNoCurrent