FDA.reportPublic FDA data

NOREPINEPHRINE BITARTRATE

Product NDC
72603-180
11-digit product format
726030180
Labeler code
72603
Product ID
72603-180_fd398152-b428-4dca-8478-b691b909ee0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norepinephrine bitartrate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
NorthStar Rx LLC
Application
ANDA217575
Marketing category
ANDA
Marketing start
2023-12-01
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
72603-180-01NOREPINEPHRINE BITARTRATE4 mL in 1 VIAL, SINGLE-DOSEINJECTION41
72603-180-10NOREPINEPHRINE BITARTRATE10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-180-01ML - Milliliter72603-18088d65577-775a-4412-9800-815c7ff6a9f812023-12-05
72603-180-10ML - Milliliter72603-1804e01c8d8-2fa9-4725-b58e-dc43f460659f12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-180NOREPINEPHRINE BITARTRATE INJECTION [NORTHSTAR RX LLC]1Current NDC, 2 package rows20231201_fd398152-b428-4dca-8478-b691b909ee0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSNfd398152-b428-4dca-8478-b691b909ee0e1
2429694 ML norepinephrine 1 MG/ML InjectionSCDfd398152-b428-4dca-8478-b691b909ee0e1
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSYfd398152-b428-4dca-8478-b691b909ee0e1
242969norepinephrine 4 MG per 4 ML InjectionSYfd398152-b428-4dca-8478-b691b909ee0e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-180-01726030180014 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical
72603-180-107260301801010 VIAL, SINGLE-DOSE in 1 CARTON (72603-180-10) / 4 mL in 1 VIAL, SINGLE-DOSE (72603-180-01) 2023-12-01NoNoCurrent