Norepinephrine bitartrate

Product NDC
31722-372
11-digit product format
317220372
Labeler code
31722
Product ID
31722-372_375cf9eb-4989-ae9e-e063-6394a90a39a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norepinephrine bitartrate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA219163
Marketing category
ANDA
Marketing start
2025-01-31
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
31722-372-31Norepinephrine bitartrate4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE41
31722-372-32Norepinephrine bitartrate10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSNbaba1002-8b62-4a24-a4e1-53e7a59c785a1
2429694 ML norepinephrine 1 MG/ML InjectionSCDbaba1002-8b62-4a24-a4e1-53e7a59c785a1
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSYbaba1002-8b62-4a24-a4e1-53e7a59c785a1
242969norepinephrine 4 MG per 4 ML InjectionSYbaba1002-8b62-4a24-a4e1-53e7a59c785a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-372-31317220372314 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical
31722-372-323172203723210 VIAL, SINGLE-DOSE in 1 CARTON (31722-372-32) / 4 mL in 1 VIAL, SINGLE-DOSE (31722-372-31) 2025-01-31NoNoCurrent